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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name unit, liquid-oxygen, portable
510(k) Number K971545
Device Name PROTEGE LIQUID OXYGEN SYSTEM
Applicant
HEALTHDYNE TECHNOLOGIES, INC.
933 WESTERN DR.
INDIANAPOLIS,  IN  46241
Applicant Contact JAY HAYES
Correspondent
HEALTHDYNE TECHNOLOGIES, INC.
933 WESTERN DR.
INDIANAPOLIS,  IN  46241
Correspondent Contact JAY HAYES
Regulation Number868.5655
Classification Product Code
BYJ  
Date Received04/28/1997
Decision Date 07/25/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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