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. Cardiovascular ✕

33 devices

1-12 of 33

Cleared Jul 14, 1995

SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM

Cardiovascular · 98d

Cleared Apr 25, 1995

HEART RATE VARIABILITY SOFTWARE OPTION

Cardiovascular · 63d

Cleared Dec 06, 1993

SPACE LABS MODEL 90560

Cardiovascular · 496d

Cleared Oct 04, 1991

SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION

Cardiovascular · 87d

Cleared Apr 12, 1991

DEFIBRILLATOR LEAD ADAPTER

Cardiovascular · 156d

Cleared Jan 31, 1991

PATIENT CARE MANAGEMENT SYSTEM MODIFICATION

Cardiovascular · 28d

Cleared Dec 27, 1990

FIRST MEDIC MODEL 510

Cardiovascular · 384d

Cleared Dec 18, 1990

LOCAL REPORT GENERATOR

Cardiovascular · 89d

Cleared Nov 30, 1989

SPACELABS MODEL 90900

Cardiovascular · 174d

Cleared Nov 25, 1986

SPACELABS - ARRHYTHMIA NET (TM) LEVEL 1

Cardiovascular · 11d

Cleared Nov 24, 1986

SPACELABS ARRHYTHMIA NET (TM) LEVEL 2

Cardiovascular · 10d

Cleared Sep 23, 1986

SPACELABS SERIES 90700 PATIENT MONITORS

Cardiovascular · 49d