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510(k) K971545

PROTEGE LIQUID OXYGEN SYSTEM by Healthdyne Technologies, Inc. — Product Code BYJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 1997
Date Received
April 28, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Liquid-Oxygen, Portable
Device Class
Class II
Regulation Number
868.5655
Review Panel
AN
Submission Type

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  • K943509 — 7300 NASAL CPAP SYSTEM (August 5, 1994)

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