Northeast Monitoring, Inc.

Northeast Monitoring, Inc.

Address:141 Parker Street, Suite # 200,MAYNARD,MA,01754,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Electrocardiograph, Ambulatory (Without Analysis) (MWJ) (8) Computer, Diagnostic, Programmable (DQK) (2)

Premarket Exempt

No

Clear

DR200 - M581NEMK1290 Catalog Number : NEMK129

Device Description : DR200 holter recorder w/ 3L patient cable

Device Class : 2

Duns Number: 837441815

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

DR181 - M581NEMK1380 Catalog Number : NEMK138

Device Description : DR181 holter recorder w/ 5L patient cable

Device Class : 2

Duns Number: 837441815

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

DR181 - M581NEMK1390 Catalog Number : NEMK139

Device Description : DR181 holter recorder w/ 7L patient cable

Device Class : 2

Duns Number: 837441815

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

DR181 - M581NEMK1400 Catalog Number :

Device Description : DR181 holter recorder w/ 10L patient cable

Device Class : 2

Duns Number: 837441815

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

DR300 - M581NEMK1540 Catalog Number : NEMK154

Device Description : DR300 holter recorder w/ 5L patient cable

Device Class : 2

Duns Number: 837441815

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

DR300 - M581NEMK1550 Catalog Number : NEMK155

Device Class : 2

Duns Number: 837441815

Premarket Exempt : No

Product Code : MWJ

Prescription Use : No

Device Count : 1

Gateway - M581NEMK1560 Catalog Number : NEMK156

Device Description : Gateway NEMK156

Device Class : 2

Duns Number: 837441815

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

DR400 - M581NEMK1570 Catalog Number : NEMK157

Device Description : DR400 holter recorder with NEMEL002/003 patches

Device Class : 2

Duns Number: 837441815

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

Holter Analysis Software - M581NEMK1600 Catalog Number : NEMK160

Device Description : Holter Analysis Software Basic

Device Class : 2

Duns Number: 837441815

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

Holter Analysis Software - M581NEMK1610 Catalog Number : NEMK161

Device Description : Holter Analysis Software Enhanced

Device Class : 2

Duns Number: 837441815

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

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