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510(k) K892006

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1989
Date Received
March 28, 1989
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.

  • K950331 — PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS) (September 21, 1995)
  • 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)
  • K890150 — H-3000 OXYGEN CONCENTRATOR (January 31, 1989)

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