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510(k) K922027

AMBULATORY (HOLTER) RECORDING, MODIFICATION by Biosensor Corp. — Product Code DSI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 1993
Date Received
March 26, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detector And Alarm, Arrhythmia
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

Other clearances by Biosensor Corp.

  • K990956 — BIOSENSOR HOLTER MONITOR SYSTEM SOFTWARE, MODEL 1005 (June 14, 1999)
  • K974546 — BIOSENSOR HOLTER MONITOR SYSTEM (March 4, 1998)
  • K974192 — BIOSENSOR HOLTER MONITOR SYSTEM (March 4, 1998)
  • K950944 — AMBULATORY (HOLTER) RECORDING SYSTEM (June 18, 1996)
  • K960449 — PC ECG 1200 ECG AND STRESS ELECTROCARDIOGRAPHY TESTING SYSTEM(VERSION 2.90) (May 30, 1996)
  • K943338 — BIOSENSOR BIDOP VASCULAR TEST SYSTEM (April 12, 1996)
  • K950723 — AMBULATORY (HOLTER) RECORDING SYSTEM (February 9, 1996)
  • K895266 — AMBULATORY (HOLTER) RECORDING SYSTEM - MODIFIED (January 26, 1990)
  • K831676 — BIOSENSOR ASC SYSTEM (December 1, 1983)

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