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FDA 510(k)

CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW

K-Number: K203078 · 2022-08-19

ApplicantHuizhou Tianchang Industrial Co., Ltd.
Decision Date2022-08-19
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW is a medical device manufactured by Huizhou Tianchang Industrial Co., Ltd.. It received FDA 510(k) clearance on 2022-08-19 under approval number K203078. 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 CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW?

CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW is a medical device that received FDA 510(k) clearance on 2022-08-19. It is manufactured by Huizhou Tianchang Industrial Co., Ltd.. The 510(k) number is K203078.

When was CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW approved by the FDA?

CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW received FDA 510(k) clearance on 2022-08-19, under approval number K203078.

What company makes CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW?

CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW is manufactured by Huizhou Tianchang Industrial Co., Ltd..

What is the FDA product code for CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW?

The FDA product code for CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW is FXX.

Related Clinical Trials

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Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

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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