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FDA 510(k)

Motex Anti-Fog Surgical Face Mask

K-Number: K201549 · 2020-08-26

Decision Date2020-08-26
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Motex Anti-Fog Surgical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Modern Healthcare Corp.. It received FDA 510(k) clearance on 2020-08-26 under 510(k) number K201549. 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 Motex Anti-Fog Surgical Face Mask?

Motex Anti-Fog Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2020-08-26. The listed applicant is Modern Healthcare Corp.. The 510(k) number is K201549.

When did Motex Anti-Fog Surgical Face Mask receive FDA 510(k) clearance?

Motex Anti-Fog Surgical Face Mask received FDA 510(k) clearance on 2020-08-26, under 510(k) number K201549.

Who is the listed applicant for Motex Anti-Fog Surgical Face Mask?

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

What is the FDA product code for Motex Anti-Fog Surgical Face Mask?

The FDA product code for Motex Anti-Fog Surgical Face Mask is FXX.

Other records listing Modern Healthcare Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: FXX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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