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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 K924146
Device Name OH-500 OXYGEN CONCENTRATOR
Applicant
Healthdyne, Inc.
1850 Pkwy. Pl., 12th Floor
Marietta,  GA  30067
Applicant Contact TIM COWART
Correspondent
Healthdyne, Inc.
1850 Pkwy. Pl., 12th Floor
Marietta,  GA  30067
Correspondent Contact TIM COWART
Regulation Number868.5440
Classification Product Code
CAW  
Date Received08/18/1992
Decision Date 01/07/1993
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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