1
B635BIOTRES100
1.0
Biotricity
BIOTRICITY INC
2
B632MDB01023
HA3P
MDB01023
Mediblu
MEDIBLU MEDICAL LLC
3
B353MM12501
MM1250
Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
MonitorMe
LIFESIGNALS, INC.
4
B353MA12511
MA1251
MA1251_US
Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
MAWI
LIFESIGNALS, INC.
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
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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.
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HOLTER CONNECT
LIFESIGNALS, INC.
9
B353LA1252C1
LA1252C
HOLTER CONNECT business logic is a software running on cloud platform that provi
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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.
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HOLTER CONNECT
LIFESIGNALS, INC.
10
B353CV12531
CV1253
CV1253_US
Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
CorVitals
LIFESIGNALS, INC.
11
B353CV12451
CV1245
Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
CORVITALS
LIFESIGNALS, INC.
12
B353AB12571
AB1257
AB1257_US
Wearable Biosensor - ECG Remote Monitoring Biosensor
Advance Biometrix
LIFESIGNALS, INC.
13
B353AB12511
AB1251
AB1251_US
Wearable Biosensor - ECG Remote Monitoring Biosensor
Advance Biometrix
LIFESIGNALS, INC.
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
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ENHANCED ALGORITHM ECG EVENT RECORDERhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=1058652#
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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