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510(k) K082256

LIFE SUPPORT FOR TRAUMA AND TRNSPORT (LSTAT) G6 LITE by Integrated Medical Systems, Inc. — Product Code MWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2008
Date Received
August 8, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

Other clearances by Integrated Medical Systems, Inc.

  • K902682 — STICK-GARD STERILE CAP (September 26, 1990)
  • K895414 — MULTIMED (TM) PULMONARY FUNCTION TESTING SYSTEM (February 12, 1990)
  • K871659 — IMS-2000S STRESS MONITOR (May 28, 1987)
  • K870934 — IMS-2000R RESTING ELECTROCARDIOGRAPHIC SYSTEM (May 6, 1987)

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