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510(k) K942357

H-500 ALLIANCE OXYGEN CONCENTRATOR by Healthdyne, Inc. — Product Code CAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1994
Date Received
May 17, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, Oxygen, Portable
Device Class
Class II
Regulation Number
868.5440
Review Panel
AN
Submission Type

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  • 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)
  • K890150 — H-3000 OXYGEN CONCENTRATOR (January 31, 1989)

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