510(k) K921125

AMBU OXYGEN REGULATOR by Amg, LLC — Product Code CAN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 1992
Date Received
March 10, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Regulator, Pressure, Gas Cylinder
Device Class
Class I
Regulation Number
868.2700
Review Panel
AN
Submission Type