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FDA 510(k)

Single-Use Surgical Mask Model FE2311B

K-Number: K210970 · 2021-07-21

ApplicantByd Precison Manufacturer Co., Ltd.
Decision Date2021-07-21
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Single-Use Surgical Mask Model FE2311B is a medical device manufactured by Byd Precison Manufacturer Co., Ltd.. It received FDA 510(k) clearance on 2021-07-21 under approval number K210970. 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 Single-Use Surgical Mask Model FE2311B?

Single-Use Surgical Mask Model FE2311B is a medical device that received FDA 510(k) clearance on 2021-07-21. It is manufactured by Byd Precison Manufacturer Co., Ltd.. The 510(k) number is K210970.

When was Single-Use Surgical Mask Model FE2311B approved by the FDA?

Single-Use Surgical Mask Model FE2311B received FDA 510(k) clearance on 2021-07-21, under approval number K210970.

What company makes Single-Use Surgical Mask Model FE2311B?

Single-Use Surgical Mask Model FE2311B is manufactured by Byd Precison Manufacturer Co., Ltd..

What is the FDA product code for Single-Use Surgical Mask Model FE2311B?

The FDA product code for Single-Use Surgical Mask Model FE2311B is 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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