Medical Device Manufacturer · US , Lexington , MA

New England Medical Instruments, Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 1991

Recent clearances: DIGITRACE HOME VIDEO SYSTEM, DIGITRACE(TM) HOME MONIT COMP/ELB(TM) EEG LUNCH BX, MCSEER/MICRO CONTROLLER SLD ST EEG EVENT RECORDER

View 3 510(k) Devices ↓

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - New England Medical Instruments, Inc. Neurology ✕

3 devices

1-3 of 3

Cleared Feb 09, 1996

DIGITRACE HOME VIDEO SYSTEM

Neurology · 50d

Cleared Dec 18, 1991

DIGITRACE(TM) HOME MONIT COMP/ELB(TM) EEG LUNCH BX

Neurology · 299d

Cleared Sep 04, 1991

MCSEER/MICRO CONTROLLER SLD ST EEG EVENT RECORDER

Neurology · 224d