Spacelabs, Inc. - FDA 510(k) Cleared Devices
46
Total
46
Cleared
0
Denied
46 devices
Cleared
Mar 19, 1986
SPACELABS AIRWAY ADAPTER SET SERIES, NO. 369014
Anesthesiology
48d
Cleared
May 28, 1985
SPACELABS-GENERAL SYSTEM LINK
Cardiovascular
98d
Cleared
Feb 14, 1985
SPACELABS MODEL 90201 HOLTER RECORDER
Cardiovascular
56d
Cleared
Feb 01, 1985
SPACELABS SERIES 600 PATIENT MONITORS
Cardiovascular
46d
Cleared
Oct 18, 1984
SPACELABS ALPHA PC PATIENT COMPUTER
Cardiovascular
105d
Cleared
Oct 04, 1984
SPACELABS ICR ARRHYTHMIA MASTER I HOLTER
Cardiovascular
86d
Cleared
Aug 24, 1984
540 CAPNOGRAPH
Anesthesiology
25d
Cleared
Apr 17, 1984
ALPHA MASS STORAGE CARDULE 1895
Cardiovascular
109d
Cleared
Feb 13, 1984
MODEL 1888 ALPHA COS/RESPIRATION CAR
General Hospital
56d
Cleared
Jan 27, 1984
ALPHA CARDIAC OUTPUT CARDULE #1899
Cardiovascular
175d
Cleared
Jan 27, 1984
ALPHA NON-INVASIVE BP CARDULE
Cardiovascular
164d
Cleared
Nov 07, 1983
ARRHYTHMIA III CARDULE #1919
Cardiovascular
89d
Cleared
Mar 17, 1983
HEARTRATE PLUS ECG CARDULE #1918
Cardiovascular
45d
Cleared
Aug 13, 1981
SPACELABS' SYSTEM AUTORECORDER
Cardiovascular
73d
Cleared
Oct 02, 1979
ARRHYTHMIA II EDITOR
Cardiovascular
22d
Cleared
May 16, 1979
ARRHYTHMIA II CARDULE
Cardiovascular
16d
Cleared
Dec 04, 1978
TELEMETRY SYSTEM, BIOTEL 300
Cardiovascular
35d
Cleared
Dec 23, 1976
SERIES 700 PATIENT MONITORS
General Hospital
10d
Cleared
Dec 09, 1976
MICRO-COMPUTER ARRHYTHONIA SYSTEM
Cardiovascular
48d
Cleared
Sep 21, 1976
SPACELABS SERIES 1000
Cardiovascular
11d
Cleared
Jul 20, 1976
PULSE CARDULE (MODEL 1859/1860 ECG)
Cardiovascular
22d