Spacelabs, Inc. - FDA 510(k) Cleared Devices
46
Total
46
Cleared
0
Denied
33 devices
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 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