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FDA 510(k)

Savewo ClassicMASK

K-Number: K221957 · 2022-09-02

ApplicantSavewo Limited
Decision Date2022-09-02
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Savewo ClassicMASK is a medical device manufactured by Savewo Limited. It received FDA 510(k) clearance on 2022-09-02 under approval number K221957. 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 Savewo ClassicMASK?

Savewo ClassicMASK is a medical device that received FDA 510(k) clearance on 2022-09-02. It is manufactured by Savewo Limited. The 510(k) number is K221957.

When was Savewo ClassicMASK approved by the FDA?

Savewo ClassicMASK received FDA 510(k) clearance on 2022-09-02, under approval number K221957.

What company makes Savewo ClassicMASK?

Savewo ClassicMASK is manufactured by Savewo Limited.

What is the FDA product code for Savewo ClassicMASK?

The FDA product code for Savewo ClassicMASK is FXX.

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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