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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Oxygen, Portable
510(k) Number K942357
Device Name H-500 ALLIANCE OXYGEN CONCENTRATOR
Applicant
Healthdyne, Inc.
1255 Kennestone Circle
Marietta,  GA  30066
Applicant Contact TIMOTHY Y COWART
Correspondent
Healthdyne, Inc.
1255 Kennestone Circle
Marietta,  GA  30066
Correspondent Contact TIMOTHY Y COWART
Regulation Number868.5440
Classification Product Code
CAW  
Date Received05/17/1994
Decision Date 05/27/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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