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510(k) K874695

HEALTHDYNE APNEA/HEART MONITOR, MODEL 900 by Healthdyne, Inc. — Product Code DRT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 1988
Date Received
November 16, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

Other clearances by Healthdyne, Inc.

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  • 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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