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FDA 510(k)

Kangbeier Surgical Mask (Model: KBR-1001)

K-Number: K213920 · 2022-01-16

ApplicantXinxiang Kangbeier Medical Technology Co., Ltd.
Decision Date2022-01-16
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Kangbeier Surgical Mask (Model: KBR-1001) is a medical device manufactured by Xinxiang Kangbeier Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-01-16 under approval number K213920. 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 Kangbeier Surgical Mask (Model: KBR-1001)?

Kangbeier Surgical Mask (Model: KBR-1001) is a medical device that received FDA 510(k) clearance on 2022-01-16. It is manufactured by Xinxiang Kangbeier Medical Technology Co., Ltd.. The 510(k) number is K213920.

When was Kangbeier Surgical Mask (Model: KBR-1001) approved by the FDA?

Kangbeier Surgical Mask (Model: KBR-1001) received FDA 510(k) clearance on 2022-01-16, under approval number K213920.

What company makes Kangbeier Surgical Mask (Model: KBR-1001)?

Kangbeier Surgical Mask (Model: KBR-1001) is manufactured by Xinxiang Kangbeier Medical Technology Co., Ltd..

What is the FDA product code for Kangbeier Surgical Mask (Model: KBR-1001)?

The FDA product code for Kangbeier Surgical Mask (Model: KBR-1001) is FXX.

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Other Devices by Xinxiang Kangbeier Medical Technology Co., Ltd.

K221753Kangbeier Child Surgical Mask

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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