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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 K843691
Device Name PORTABLE OXYGEN UNIT
Applicant
B & F Medical Products, Inc.
P.O. Box 3656
Toledo ,  OH  43608
Applicant Contact JAMES SPILLIS
Correspondent
B & F Medical Products, Inc.
P.O. Box 3656
Toledo ,  OH  43608
Correspondent Contact JAMES SPILLIS
Regulation Number868.5440
Classification Product Code
CAW  
Date Received09/19/1984
Decision Date 11/07/1984
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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