510(k) K851171

COMBIBAG MANUAL RESUSCITATOR by Frontline Medical Corp. — Product Code BTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 1985
Date Received
March 22, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Emergency, Manual (Resuscitator)
Device Class
Class II
Regulation Number
868.5915
Review Panel
AN
Submission Type