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510(k) K945985

PC HOLTER SCANNING SYSTEM SIMPLICITY, ALTAIR 8200, 8300, 8400 by Burdick, Inc. — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 1995
Date Received
December 8, 1994
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 Burdick, Inc.

  • K952417 — QUEST EXERCISE STRESS SYSTEM (May 22, 1996)
  • K954267 — BURDICK 200 PULSE OXIMETER (May 3, 1996)
  • K946281 — ECLIPSE 4 ELECTROCARDIOGRAPH (April 23, 1996)
  • K943959 — ECLIPSE 4 ELECTROCARDIOGRAPH (May 17, 1995)
  • K942565 — ALTAIR-DISC RECORDER (December 5, 1994)
  • K941351 — BURDICK PRO2 OXIMETER (October 13, 1994)
  • K942438 — ALTAIR 6100 CASSETTE RECORDER (August 5, 1994)
  • K903565 — E560 ELECTROCARDIOGRAPH (July 24, 1991)
  • K904032 — ELITE II ELECTROCARDIOGRAPH (July 24, 1991)
  • K900729 — NEOSERV 824 (June 8, 1990)

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