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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 K013472
Device Name TOTAL O2
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 Number868.5440
Classification Product Code
CAW  
Date Received10/18/2001
Decision Date 11/28/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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