Other products from "NORTHEAST MONITORING, INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 M581NEMK1570 DR400 NEMK157 DR400 holter recorder with NEMEL002/003 patches MWJ Electrocardiograph, Ambulatory (Without Analysis) 2 DR400
2 M581NEMK1610 Enhanced NEMK161 Holter Analysis Software Enhanced DQK Computer, Diagnostic, Programmable 2 Holter Analysis Software
3 M582NEMK1270 Holter Analysis Software Apnea M582NEMK127 Holter Analysis Software Apnea MNR Ventilatory Effort Recorder 2 Holter Analysis Software Apnea
4 M581NEMK1630 Pro NEMK163 Holter Analysis Software Pro DQK Computer, Diagnostic, Programmable 2 Holter Analysis Software
5 M581NEMK1620 Enhanced Plus NEMK162 Holter Analysis Enhanced Plus DQK Computer, Diagnostic, Programmable 2 Holter Analysis Software
6 M581NEMK1600 Basic NEMK160 Holter Analysis Software Basic DQK Computer, Diagnostic, Programmable 2 Holter Analysis Software
7 M581NEMK1560 Gateway NEMK156 Gateway NEMK156 MWJ Electrocardiograph, Ambulatory (Without Analysis) 2 Gateway
8 M581NEMK940 DR200 2L NEMK94 DR200 holter recorder w/ 2L patient cable MWJ Electrocardiograph, Ambulatory (Without Analysis) 2 DR200
9 M581NEMK960 DR200 7L NEMK96 DR200 holter recorder w/ 7L patient cable MWJ Electrocardiograph, Ambulatory (Without Analysis) 2 DR200
10 M581NEMK950 DR200 5L NEMK95 DR200 holter recorder w/ 5L patient cable MWJ Electrocardiograph, Ambulatory (Without Analysis) 2 DR200
11 M581NEMK1290 DR200 3L NEMK129 DR200 holter recorder w/ 3L patient cable MWJ Electrocardiograph, Ambulatory (Without Analysis) 2 DR200
12 M581NEMK1950 LX Event Tool NEMK195 LX Event Tool (TelePro) MWJ Electrocardiograph, Ambulatory (Without Analysis) 2 LX Event
13 M581NEMK1550 DR300 7L NEMK155 MWJ Electrocardiograph, Ambulatory (Without Analysis) 2 DR300
14 M581NEMK1540 DR300 5L NEMK154 DR300 holter recorder w/ 5L patient cable MWJ Electrocardiograph, Ambulatory (Without Analysis) 2 DR300
15 M581NEMK1400 DR181 12L DR181 holter recorder w/ 10L patient cable MWJ Electrocardiograph, Ambulatory (Without Analysis) 2 DR181
16 M581NEMK1390 DR181 7L NEMK139 DR181 holter recorder w/ 7L patient cable MWJ Electrocardiograph, Ambulatory (Without Analysis) 2 DR181
Other products with the same Product Code "MWJ"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 B635BIOTRES100 1.0 Biotricity BIOTRICITY INC
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5 B353LP12531 LP1253 LP1253_US Wearable Biosensor - ECG Remote Monitoring Biosensor Patch LifeSignals LIFESIGNALS, INC.
6 B353LP12511 LP1251 LP1251_US Wearable Biosensor - ECG Remote Monitoring Biosensor LifeSignals LIFESIGNALS, INC.
7 B353LP12501 LP1250 Wearable Biosensor - ECG Remote Monitoring Biosensor Patch LifeSignals LIFESIGNALS, INC.
8 B353LA1252R1 LA1252R HOLTER CONNECT Relay Application is a software that is installed on a compatible HOLTER CONNECT Relay Application is a software that is installed on a compatible commercially available platform (mobile or tablet) that manages secured wireless communication between the Biosensor and the HOLTER CONNECT Secure Server for transferring acquired ECG data by the Biosensor. HOLTER CONNECT LIFESIGNALS, INC.
9 B353LA1252C1 LA1252C HOLTER CONNECT business logic is a software running on cloud platform that provi HOLTER CONNECT business logic is a software running on cloud platform that provides interface for technician to generate Holter report on ECG data of patient, provides interface for physician to access and e-sign the Holter Report generated by the ECG technician. HOLTER CONNECT LIFESIGNALS, INC.
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14 B329AWVC23 Cardio 08-603 Ambulatory ECG recorder with accelerometer - single channel Actiwave CAMNTECH LIMITED
15 B329AWV04E22 4E 08-557 Ambulatory ECG/EEG recorder - four channel Actiwave CAMNTECH LIMITED
16 B329AWV02M25 2M 08-536 Ambulatory Electromyogram (EMG) - two channel Actiwave CAMNTECH LIMITED
17 B329AWV02E25 2E 08-521 Ambulatory ECG/EEG recorder - two channel Actiwave CAMNTECH LIMITED
18 B329AWV01E22 1E 08-514 Ambulatory ECG/EEG recorder - single channel Actiwave CAMNTECH LIMITED
19 B146PERP0 900-0553-06 ENHANCED ALGORITHM ECG EVENT RECORDER PER900 Preventice BRAEMAR MANUFACTURING, LLC
20 B146PERB0 900-0553-03 ENHANCED ALGORITHM ECG EVENT RECORDER PER900 Braemar BRAEMAR MANUFACTURING, LLC
21 B146ER9RAF0 900-0557-07 ENHANCED ALGORITHM ECG EVENT RECORDER ER920 Rozinn, AFIB BRAEMAR MANUFACTURING, LLC
22 B146ER9R0 900-0557-06 https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& ENHANCED ALGORITHM ECG EVENT RECORDER ER920 Rozinn BRAEMAR MANUFACTURING, LLC
23 B146ER9BAF0 900-0557-03 ENHANCED ALGORITHM ECG EVENT RECORDER ER920 Braemar, AFIB BRAEMAR MANUFACTURING, LLC
24 B146ER9B0 900-0557-01 ENHANCED ALGORITHM ECG EVENT RECORDERhttps://gudid.fda.gov/gudid/app/admin/udi/r ENHANCED ALGORITHM ECG EVENT RECORDERhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=1058652# ER920 Braemar BRAEMAR MANUFACTURING, LLC
25 B146DL9ZW0 900-0570-25 DL900 BRAEMAR MANUFACTURING, LLC
26 B146DL9ST0 900-0570-27 Holter Recorder DL900 Standard BRAEMAR MANUFACTURING, LLC
27 B146DL9RA0 900-0570-14 Holter Recorder DL900 Remote Analysis BRAEMAR MANUFACTURING, LLC
28 B146DL9NV0 900-0570-15 Holter Recorder DL900 Norav 7 day CE BRAEMAR MANUFACTURING, LLC
29 B146DL9NE0 900-0570-24 Holter Recorder DL900 Norav Encrypted BRAEMAR MANUFACTURING, LLC
30 B146DL9FM0 900-0570-23 Holter Recorder DL900 Forest Medical BRAEMAR MANUFACTURING, LLC
31 B146DL9BS0 900-0570-26 Holter Recorder DL900 Base BRAEMAR MANUFACTURING, LLC
32 B146DL9BK0 900-0570-19 Holter Recorder DL900 Burdick 4250 BRAEMAR MANUFACTURING, LLC
33 B146DL9BD0 900-0570-20 Holter Recorder DL900 Biomedical SyS BRAEMAR MANUFACTURING, LLC
34 B146DL9B70 900-0570-16 Holter Recorder DL900 Braemar 7day BRAEMAR MANUFACTURING, LLC
35 B146DL9B0 900-0570-10 Holter Recorder DL900 Braemar SD BRAEMAR MANUFACTURING, LLC
36 B146DL9AT0 900-0570-12 Holter Recorder DL900 Amedtec SD BRAEMAR MANUFACTURING, LLC
37 B146DL95030 900-0616-03 DL950 Braemar Standard BRAEMAR MANUFACTURING, LLC
38 B146DL95020 900-0616-02 DL950 Braemar Base BRAEMAR MANUFACTURING, LLC
39 B146DL95010 900-0616-01 DL950 Braemar BRAEMAR MANUFACTURING, LLC
40 B146DL95000 900-0616-00 DL950 Braemar BRAEMAR MANUFACTURING, LLC
41 B146DL9280 900-0570-28 DL900 BRAEMAR MANUFACTURING, LLC
42 B146DL8NVE0 900-0543-21 DL800 Holter recorder DL800 Norav Encrypted BRAEMAR MANUFACTURING, LLC
43 B146DL8NV0 900-0543-20 Holter Recorder DL800 Norav BRAEMAR MANUFACTURING, LLC
44 B146DL8NO2560 900-0543-12 Holter Monitor DL800 Norav 256 s/s 8bit BRAEMAR MANUFACTURING, LLC
45 B146DL8FM0 900-0543-17 Holter Recorder DL800 Forest Medical 256 s/s 8 bit BRAEMAR MANUFACTURING, LLC
46 B146DL8CN0 900-0543-15 Holter Monitor DL800 CardioNet BRAEMAR MANUFACTURING, LLC
47 B146DL8CL0 900-0543-11 Holter Recorder DL800 CardioLabs BRAEMAR MANUFACTURING, LLC
48 B146DL8BD0 900-0543-19 Holter Recorder DL800 Biomedical SYS BRAEMAR MANUFACTURING, LLC
49 B146DL8B1330 900-0543-04 Holter Recorder DL800 Braemar 133 s/s BRAEMAR MANUFACTURING, LLC
50 B146DL8256B0 900-0543-09 Holter Recorder DL800 Braemar 256 s/s 10 bit BRAEMAR MANUFACTURING, LLC