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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 K854374
Device Name OXYGEN CONCENTRATOR, MODEL BX-5000
Applicant
Healthdyne, Inc.
1850 Pkwy. Pl., 12th Floor
Marietta,  GA  30067
Applicant Contact RICHARD SHEFFIELD
Correspondent
Healthdyne, Inc.
1850 Pkwy. Pl., 12th Floor
Marietta,  GA  30067
Correspondent Contact RICHARD SHEFFIELD
Regulation Number868.5440
Classification Product Code
CAW  
Date Received10/30/1985
Decision Date 01/03/1986
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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