FDA 510(k)

Puffin Lite Infant Resuscitation System

Número K: K182956 · 2019-01-18

Data da decisão2019-01-18

Código do produtoBTL

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Outros registros que listam International Biomedical como candidato(a)

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Fonte oficial

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