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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Conserver, Oxygen
510(k) Number K010389
Device Name CHAD THERAPEUTICS OXYMATIC MODEL 401 AND OXYMATIC MODEL 411
Applicant
CHAD THERAPEUTICS, INC.
21622 PLUMMER ST.
CHATSWORTH,  CA  91311
Applicant Contact KEVIN MCCULLOH
Correspondent
CHAD THERAPEUTICS, INC.
21622 PLUMMER ST.
CHATSWORTH,  CA  91311
Correspondent Contact KEVIN MCCULLOH
Regulation Number868.5905
Classification Product Code
NFB  
Date Received02/09/2001
Decision Date 03/23/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Special
Reviewed by Third Party No
Combination Product No
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