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510(k) K990956

BIOSENSOR HOLTER MONITOR SYSTEM SOFTWARE, MODEL 1005 by Biosensor Corp. — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1999
Date Received
March 22, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Programmable
Device Class
Class II
Regulation Number
870.1425
Review Panel
CV
Submission Type

Other clearances by Biosensor Corp.

  • 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)
  • K895266 — AMBULATORY (HOLTER) RECORDING SYSTEM - MODIFIED (January 26, 1990)
  • K831676 — BIOSENSOR ASC SYSTEM (December 1, 1983)

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