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510(k) K875031

OXYGEN/PULSE MONITOR by Healthdyne, Inc. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1988
Date Received
December 7, 1987
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 Healthdyne, Inc.

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  • K922106 — ALICE (July 6, 1994)
  • K942357 — H-500 ALLIANCE OXYGEN CONCENTRATOR (May 27, 1994)
  • K934502 — FLOW SPIROMETER (April 4, 1994)
  • K924146 — OH-500 OXYGEN CONCENTRATOR (January 7, 1993)
  • K922623 — NEBULIZER SYSTEM (December 1, 1992)
  • K910118 — DATA RECORDER (February 14, 1991)
  • K903287 — MODEL 900S APNEA/HEART MONITOR (August 17, 1990)
  • K894030 — MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR (January 22, 1990)
  • K892006 — HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S (May 23, 1989)

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