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510(k) K954267

BURDICK 200 PULSE OXIMETER by Burdick, Inc. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1996
Date Received
September 12, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
Submission Type

Other clearances by Burdick, Inc.

  • K952417 — QUEST EXERCISE STRESS SYSTEM (May 22, 1996)
  • K946281 — ECLIPSE 4 ELECTROCARDIOGRAPH (April 23, 1996)
  • K945985 — PC HOLTER SCANNING SYSTEM SIMPLICITY, ALTAIR 8200, 8300, 8400 (July 3, 1995)
  • 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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