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FDA 510(k)

ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400G

K-Number: K203376 · 2022-03-02

ApplicantMedtecs (Taiwan) Corp.
Decision Date2022-03-02
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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