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FDA 510(k)

MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag

K-Number: K193191 · 2020-11-20

ApplicantWeinmann Emergency Medical Technology GmbH + Co. KG
Decision Date2020-11-20
Product CodeBTL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag is the device name listed in this FDA 510(k) record. The listed applicant is Weinmann Emergency Medical Technology GmbH + Co. KG. It received FDA 510(k) clearance on 2020-11-20 under 510(k) number K193191. The device is classified under product code BTL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag?

MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag is a medical device that received FDA 510(k) clearance on 2020-11-20. The listed applicant is Weinmann Emergency Medical Technology GmbH + Co. KG. The 510(k) number is K193191.

When did MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag receive FDA 510(k) clearance?

MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag received FDA 510(k) clearance on 2020-11-20, under 510(k) number K193191.

Who is the listed applicant for MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag?

The FDA 510(k) record lists Weinmann Emergency Medical Technology GmbH + Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag?

The FDA product code for MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag is BTL.

Related Devices (Code: BTL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242769VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)Draegerwerk AG & CO KgaaK221634Oxymag - Transport and Emergency VentilatorMagnamed Tecnologia Medica S/AK202219VORTRAN GO2VENT with PEEP ValveVortran Medical Technology 1, Inc.K182956Puffin Lite Infant Resuscitation SystemInternational BiomedicalK173373SafeT T-Piece ResuscitatorVentlab, LLCK161420MOVES SLCThornhill Research, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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