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510(k) Clearances
/ K894093
510(k) K894093
SPACELABS MODEL 90900 by
Spacelabs, Inc.
— Product Code
LOS
Clearance Details
Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 1989
Date Received
June 9, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No
Other clearances by Spacelabs, Inc.
K954962
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— SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM (July 14, 1995)
K950779
— HEART RATE VARIABILITY SOFTWARE OPTION (April 25, 1995)
K941165
— COMET CAPNOGRAPH MODULE (October 6, 1994)
K923788
— SPACE LABS MODEL 90560 (December 6, 1993)
K912742
— ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE (April 20, 1992)
K913038
— SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION (October 4, 1991)
K905065
— DEFIBRILLATOR LEAD ADAPTER (April 12, 1991)
K910029
— PATIENT CARE MANAGEMENT SYSTEM MODIFICATION (January 31, 1991)
K896903
— FIRST MEDIC MODEL 510 (December 27, 1990)
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— EKG-PLUS II SOFTWARE (August 26, 2009)
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— CARDIOTOUCH-3000 (November 14, 2002)
K011328
— CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH (November 21, 2001)
K993616
— CARDIO-CARD INTERPRETATION SYSTEM I (April 10, 2000)
K984465
— OXYCONALPHA WITH OPTION ECG (October 27, 1999)
K991014
— CASE 8000 EXERCISE TESTING SYSTEM (October 20, 1999)
K991735
— MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6, MAC VU, MAC 8 (August 19, 1999)
K990031
— NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCESSORIES (April 16, 1999)