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510(k) K870934

IMS-2000R RESTING ELECTROCARDIOGRAPHIC SYSTEM by Integrated Medical Systems, Inc. — Product Code DXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1987
Date Received
March 9, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Pre-Programmed, Single-Function
Device Class
Class II
Regulation Number
870.1435
Review Panel
CV
Submission Type

Other clearances by Integrated Medical Systems, Inc.

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  • K895414 — MULTIMED (TM) PULMONARY FUNCTION TESTING SYSTEM (February 12, 1990)
  • K871659 — IMS-2000S STRESS MONITOR (May 28, 1987)

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