510(k) K193191

MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag by Weinmann Emergency Medical Technology GmbH + Co. KG — Product Code BTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2020
Date Received
November 19, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Emergency, Powered (Resuscitator)
Device Class
Class II
Regulation Number
868.5925
Review Panel
AN
Submission Type