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510(k) K960449

PC ECG 1200 ECG AND STRESS ELECTROCARDIOGRAPHY TESTING SYSTEM(VERSION 2.90) by Biosensor Corp. — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 1996
Date Received
January 30, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph
Device Class
Class II
Regulation Number
870.2340
Review Panel
CV
Submission Type

Other clearances by Biosensor Corp.

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  • K950944 — AMBULATORY (HOLTER) RECORDING SYSTEM (June 18, 1996)
  • K943338 — BIOSENSOR BIDOP VASCULAR TEST SYSTEM (April 12, 1996)
  • K950723 — AMBULATORY (HOLTER) RECORDING SYSTEM (February 9, 1996)
  • K922027 — AMBULATORY (HOLTER) RECORDING, MODIFICATION (February 17, 1993)
  • K895266 — AMBULATORY (HOLTER) RECORDING SYSTEM - MODIFIED (January 26, 1990)
  • K831676 — BIOSENSOR ASC SYSTEM (December 1, 1983)

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