FDA 510(k)

3 camadas EcoGuard B com Orelha, 3 camadas EcoGuard B com Ganchos

Número K: K202096 · 2021-02-02

Data da decisão2021-02-02

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On is the device name listed in this FDA 510(k) record. The listed applicant is Ecoguard, Inc.. It received FDA 510(k) clearance on 2021-02-02 under 510(k) number K202096. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the 3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On?

3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On is a medical device that received FDA 510(k) clearance on 2021-02-02. The listed applicant is Ecoguard, Inc.. The 510(k) number is K202096.

When did 3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On receive FDA 510(k) clearance?

3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On received FDA 510(k) clearance on 2021-02-02, under 510(k) number K202096.

Who is the listed applicant for 3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On?

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

What is the FDA product code for 3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On?

The FDA product code for 3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On is FXX.

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