510(k) K841901

OXYMIZER FLOW RESTRICTOR by Chad Therapeutics, Inc. — Product Code BYX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1984
Date Received
May 7, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubing, Pressure And Accessories
Device Class
Class I
Regulation Number
868.5860
Review Panel
AN
Submission Type