Cleared Traditional

MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag

K193191 · Weinmann Emergency Medical Technology GmbH + Co. KG · Anesthesiology

Nov 2020

Decision

367d

Days

Class 2

Risk

About This 510(k) Submission

K193191 is an FDA 510(k) clearance for the MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag, a Ventilator, Emergency, Powered (resuscitator) (Class II — Special Controls, product code BTL), submitted by Weinmann Emergency Medical Technology GmbH + Co. KG (Hamburg, DE). The FDA issued a Cleared decision on November 20, 2020, 367 days after receiving the submission on November 19, 2019. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5925.

Submission Details

510(k) Number	K193191 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 19, 2019
Decision Date	November 20, 2020
Days to Decision	367 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF