FDA 510(k)

MTS Imipenem-relebactam 0.002/4-32/4 µg/mL

Número K: K191809 · 2019-08-23

Data da decisão2019-08-23

Código do produtoJWY

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

MTS Imipenem-relebactam 0.002/4-32/4 µg/mL is the device name listed in this FDA 510(k) record. The listed applicant is Liofilchem s.r.l.. It received FDA 510(k) clearance on 2019-08-23 under 510(k) number K191809. The device is classified under product code JWY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MTS Imipenem-relebactam 0.002/4-32/4 µg/mL?

MTS Imipenem-relebactam 0.002/4-32/4 µg/mL is a medical device that received FDA 510(k) clearance on 2019-08-23. The listed applicant is Liofilchem s.r.l.. The 510(k) number is K191809.

When did MTS Imipenem-relebactam 0.002/4-32/4 µg/mL receive FDA 510(k) clearance?

MTS Imipenem-relebactam 0.002/4-32/4 µg/mL received FDA 510(k) clearance on 2019-08-23, under 510(k) number K191809.

Who is the listed applicant for MTS Imipenem-relebactam 0.002/4-32/4 µg/mL?

The FDA 510(k) record lists Liofilchem s.r.l. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MTS Imipenem-relebactam 0.002/4-32/4 µg/mL?

The FDA product code for MTS Imipenem-relebactam 0.002/4-32/4 µg/mL is JWY.

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Fonte oficial

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