510(k) K000890

CHAD THERAPEUTICS OXYMATIC MODEL 401 by Chad Therapeutics, Inc. — Product Code NFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2000
Date Received
March 20, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Conserver, Oxygen
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type