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FDA 510(k)

Surgical Face Mask (Model: CM2006, CM2008, A88)

K-Number: K210878 · 2021-09-28

ApplicantShenzhen Realtone Medical Appliance Co., Ltd.
Decision Date2021-09-28
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surgical Face Mask (Model: CM2006, CM2008, A88) is a medical device manufactured by Shenzhen Realtone Medical Appliance Co., Ltd.. It received FDA 510(k) clearance on 2021-09-28 under approval number K210878. 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 Surgical Face Mask (Model: CM2006, CM2008, A88)?

Surgical Face Mask (Model: CM2006, CM2008, A88) is a medical device that received FDA 510(k) clearance on 2021-09-28. It is manufactured by Shenzhen Realtone Medical Appliance Co., Ltd.. The 510(k) number is K210878.

When was Surgical Face Mask (Model: CM2006, CM2008, A88) approved by the FDA?

Surgical Face Mask (Model: CM2006, CM2008, A88) received FDA 510(k) clearance on 2021-09-28, under approval number K210878.

What company makes Surgical Face Mask (Model: CM2006, CM2008, A88)?

Surgical Face Mask (Model: CM2006, CM2008, A88) is manufactured by Shenzhen Realtone Medical Appliance Co., Ltd..

What is the FDA product code for Surgical Face Mask (Model: CM2006, CM2008, A88)?

The FDA product code for Surgical Face Mask (Model: CM2006, CM2008, A88) 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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