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. Anesthesiology ✕

4 devices

1-4 of 4

Cleared Apr 19, 2006

SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES

Anesthesiology · 117d

Cleared Jun 28, 2001

SPACELABS MEDICAL ANESTHESIA DELIVERY SYSTEM (ADS) WITH PRESSURE CONTROL MODE

Anesthesiology · 212d

Cleared Dec 03, 1999

SPACELABS MEDICAL DISPOSABLE SP02 SENSOR

Anesthesiology · 571d

Cleared Nov 20, 1998

SPACELABS MEDICAL 90519 ANESTHESIA DELIVERY SYSTEM

Anesthesiology · 205d