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

35 devices

26-35 of 35

Cleared Apr 02, 1997

SPACELABS MEDICAL INTEGRATED MULTI-PARAMETER MODULE

Cardiovascular · 646d

Cleared Mar 25, 1997

SPACELABS MEDICAL 12-LEAD DIAGNOSTIC ECG ANALYSIS OPTION

Cardiovascular · 237d

Cleared Sep 26, 1995

SINGLE LEAD DIGITAL TELEMETRY TRANSMITTER

Cardiovascular · 95d

Cleared Aug 15, 1995

SPACELABS MEDICAL EXPANSION MODULE (MODEL 90352)

Cardiovascular · 281d

Cleared May 17, 1995

SPACELABS MEDICAL ECG MODULE (MODEL 90492)

Cardiovascular · 383d

Cleared Nov 14, 1994

NON-INVASIVE BLOOD PRESSURE (NIBP) MONITOR (MODEL 90553)

Cardiovascular · 245d

Cleared Oct 27, 1994

MODEL 90478 & 90479 TELEMETRY REC. MODULE&HOUSING

Cardiovascular · 727d

Cleared Mar 02, 1994

SPACELABS MEDICAL MODEL 90481 EEG MODULE

Neurology · 264d

Cleared Nov 05, 1993

SPACELABS MEDICAL INTEGRATED CLINICAL DISPLAY

Cardiovascular · 151d

Cleared Sep 03, 1993

SPACELABS MEDICAL PATIENT MONITOR

Cardiovascular · 238d