Medical Device Manufacturer · US , Brookline , MA

Core-M, Inc. - FDA 510(k) Cleared Devices

3 submissions · 2 cleared · Since 1989

3

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Core-M, Inc. Anesthesiology ✕

3 devices

1-3 of 3

Cleared Aug 19, 1996

OMICRON MONITOR, DELTA MONITOR

Anesthesiology · 171d

Cleared Nov 17, 1992

BREATH TRACKER(TM) MODEL 1800 CAN-O-GAUGE

Anesthesiology · 203d

Cleared Jun 23, 1989

Anesthesiology · 63d