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510(k) K924146

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 1993
Date Received
August 18, 1992
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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  • K890150 — H-3000 OXYGEN CONCENTRATOR (January 31, 1989)

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