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FDA 510(k)

M1 Surgical Face Mask

K-Number: K202457 · 2021-04-29

ApplicantCHISON Medical Technologies Co., Ltd.
Decision Date2021-04-29
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

M1 Surgical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is CHISON Medical Technologies Co., Ltd.. It received FDA 510(k) clearance on 2021-04-29 under 510(k) number K202457. 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 M1 Surgical Face Mask?

M1 Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2021-04-29. The listed applicant is CHISON Medical Technologies Co., Ltd.. The 510(k) number is K202457.

When did M1 Surgical Face Mask receive FDA 510(k) clearance?

M1 Surgical Face Mask received FDA 510(k) clearance on 2021-04-29, under 510(k) number K202457.

Who is the listed applicant for M1 Surgical Face Mask?

The FDA 510(k) record lists CHISON Medical Technologies Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for M1 Surgical Face Mask?

The FDA product code for M1 Surgical Face Mask is FXX.

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Related Devices (Code: FXX)

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Official Source

View on FDA Database →

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

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