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FDA 510(k)

Puffin Lite Infant Resuscitation System

K-Number: K182956 · 2019-01-18

ApplicantInternational Biomedical
Decision Date2019-01-18
Product CodeBTL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Puffin Lite Infant Resuscitation System is a medical device manufactured by International Biomedical. It received FDA 510(k) clearance on 2019-01-18 under approval number K182956. 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 Puffin Lite Infant Resuscitation System?

Puffin Lite Infant Resuscitation System is a medical device that received FDA 510(k) clearance on 2019-01-18. It is manufactured by International Biomedical. The 510(k) number is K182956.

When was Puffin Lite Infant Resuscitation System approved by the FDA?

Puffin Lite Infant Resuscitation System received FDA 510(k) clearance on 2019-01-18, under approval number K182956.

What company makes Puffin Lite Infant Resuscitation System?

Puffin Lite Infant Resuscitation System is manufactured by International Biomedical.

What is the FDA product code for Puffin Lite Infant Resuscitation System?

The FDA product code for Puffin Lite Infant Resuscitation System is BTL.

Related Clinical Trials

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Related Devices (Code: BTL)

K161420MOVES SLCThornhill Research, Inc. K162968VORTRAN GO2VENTVortran Medical Technology 1, Inc. K173373SafeT T-Piece ResuscitatorVentlab, LLC K193191MEDUMAT Easy CPR, MEDUMAT Easy CPR with bagWeinmann Emergency Medical Technology GmbH + Co. KG K202219VORTRAN GO2VENT with PEEP ValveVortran Medical Technology 1, Inc. K221634Oxymag - Transport and Emergency VentilatorMagnamed Tecnologia Medica S/A

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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