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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Emergency, Powered (Resuscitator)
510(k) Number K193191
Device Name MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag
Applicant
Weinmann Emergency Medical Technology GmbH + Co. KG
Frohbösestraße 12
Hamburg,  DE 22525
Applicant Contact Kristin Ratschiller
Correspondent
Weinmann Emergency Medical Technology GmbH + Co. KG
Frohbösestraße 12
Hamburg,  DE 22525
Correspondent Contact Kristin Ratschiller
Regulation Number868.5925
Classification Product Code
BTL  
Date Received11/19/2019
Decision Date 11/20/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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