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510(k) K895266

AMBULATORY (HOLTER) RECORDING SYSTEM - MODIFIED by Biosensor Corp. — Product Code DSI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1990
Date Received
August 23, 1989
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)
  • K922027 — AMBULATORY (HOLTER) RECORDING, MODIFICATION (February 17, 1993)
  • K831676 — BIOSENSOR ASC SYSTEM (December 1, 1983)

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