FDA 510(k)

Mercy babyTAPE

Número K: K191174 · 2019-10-10

Data da decisão2019-10-10

Código do produtoPIR

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Mercy babyTAPE is the device name listed in this FDA 510(k) record. The listed applicant is Children'S Mercy Hospital. It received FDA 510(k) clearance on 2019-10-10 under 510(k) number K191174. The device is classified under product code PIR. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Mercy babyTAPE?

Mercy babyTAPE is a medical device that received FDA 510(k) clearance on 2019-10-10. The listed applicant is Children'S Mercy Hospital. The 510(k) number is K191174.

When did Mercy babyTAPE receive FDA 510(k) clearance?

Mercy babyTAPE received FDA 510(k) clearance on 2019-10-10, under 510(k) number K191174.

Who is the listed applicant for Mercy babyTAPE?

The FDA 510(k) record lists Children'S Mercy Hospital as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mercy babyTAPE?

The FDA product code for Mercy babyTAPE is PIR.

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