FDA 510(k)

ASTM Nível 1/EN14683 Tipo IIR 3-Ply Máscara Cirúrgica descartável, Número de modelo: FM-1400G

Número K: K203376 · 2022-03-02

Data da decisão2022-03-02

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400G is the device name listed in this FDA 510(k) record. The listed applicant is Medtecs (Taiwan) Corp.. It received FDA 510(k) clearance on 2022-03-02 under 510(k) number K203376. 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 ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400G?

ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400G is a medical device that received FDA 510(k) clearance on 2022-03-02. The listed applicant is Medtecs (Taiwan) Corp.. The 510(k) number is K203376.

When did ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400G receive FDA 510(k) clearance?

ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400G received FDA 510(k) clearance on 2022-03-02, under 510(k) number K203376.

Who is the listed applicant for ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400G?

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

What is the FDA product code for ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400G?

The FDA product code for ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400G is FXX.

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