Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is International Biomedical. It received FDA 510(k) clearance on 2019-01-18 under 510(k) 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. The listed applicant is International Biomedical. The 510(k) number is K182956.

When did Puffin Lite Infant Resuscitation System receive FDA 510(k) clearance?

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

Who is the listed applicant for Puffin Lite Infant Resuscitation System?

The FDA 510(k) record lists International Biomedical as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing International Biomedical as applicant

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.

K221154Infant Heel WarmerTM; Heel Snuggler®K221653InfaTherm Disposable Infant Warming MattressK220742NxtGen Infant Transport IncubatorK193481AeroNOx 2.0 Nitric Oxide Titration & Monitoring SystemK173516NuBorne Infant WarmerK160238Airborne Phototherapy Light

View all 7 devices →

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.K193191MEDUMAT Easy CPR, MEDUMAT Easy CPR with bagWeinmann Emergency Medical Technology GmbH + Co. KGK173373SafeT 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.

↑