Medical Device Manufacturer · US , Hamden , CT

Spacelabs Medical, Inc. - FDA 510(k) Cleared Devices

35 submissions · 34 cleared · Since 1993

35

Total

34

Cleared

0

Denied

FDA 510(k) Regulatory Record - Spacelabs Medical, Inc. Neurology ✕

3 devices

1-3 of 3

Cleared Jun 23, 2006

SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND...

Neurology · 81d

Cleared Feb 03, 1998

SPACELABS MEDICAL 90482 BISPECTRAL INDEX ANALYSIS (BIS) MODULE

Neurology · 134d

Cleared Mar 02, 1994

SPACELABS MEDICAL MODEL 90481 EEG MODULE

Neurology · 264d