Medical Device Manufacturer · US , Sudbury , MA

North East Monitoring, Inc. - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 1995

10

Total

10

Cleared

0

Denied

FDA 510(k) Regulatory Record - North East Monitoring, Inc. Cardiovascular ✕

8 devices

1-8 of 8

Cleared Nov 25, 2014

DR300 HOLTER MONITOR

Cardiovascular · 88d

Cleared May 25, 2007

AUTO DETECT FOR TELAHEART DR200/E-A

Cardiovascular · 142d

Cleared Aug 25, 2006

TELAHEART DIGITAL RECORDER

Cardiovascular · 108d

Cleared Aug 31, 2004

SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER

Cardiovascular · 48d

Cleared Jan 25, 2001

Cardiovascular · 30d

Cleared Jul 20, 2000

Cardiovascular · 87d

Cleared Jul 31, 1996

NORTHEAST MONITORING DR180

Cardiovascular · 147d

Cleared Apr 19, 1995

HOLTER FOR WINDOWS

Cardiovascular · 805d