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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 PARKWAY PLACE, 12TH FLOOR
MARIETTA,  GA  30067 -8274
Applicant Contact RICHARD SHEFFIELD
Correspondent
HEALTHDYNE, INC.
1850 PARKWAY PLACE, 12TH FLOOR
MARIETTA,  GA  30067 -8274
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
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