Medical Device Manufacturer · US , Mchenry , IL

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

46 submissions · 46 cleared · Since 1976

Official Website

46

Total

46

Cleared

0

Denied

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

9 devices

1-9 of 9

Cleared May 31, 1996

SPACELABS MEDICAL MULTIGAS ANALYZER

Anesthesiology · 214d

Cleared Oct 06, 1994

COMET CAPNOGRAPH MODULE

Anesthesiology · 209d

Cleared Oct 19, 1990

MODEL 90421 FLEXPORT INTERFACE

Anesthesiology · 80d

Cleared Apr 30, 1990

MODEL 90489 PULSE OXIMETER MODULE

Anesthesiology · 47d

Cleared Jan 24, 1990

SPACELABS' MODEL 90514, MULTIGAS ANALYZER

Anesthesiology · 77d

Cleared Sep 13, 1989

CARDIAC OUTPUR/SATURATED VENOUS OXYGEN MODULE

Anesthesiology · 110d

Cleared Mar 11, 1987

SPACELABS MODEL 90419 PULSE OXIMETER MODULE

Anesthesiology · 132d

Cleared Mar 19, 1986

SPACELABS AIRWAY ADAPTER SET SERIES, NO. 369014

Anesthesiology · 48d

Cleared Aug 24, 1984

Anesthesiology · 25d