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FDA 510(k)

Perfetta Moderate Medical Face Mask

K-Number: K222426 · 2022-09-02

ApplicantPhu Bao Group Company Limited
Decision Date2022-09-02
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Perfetta Moderate Medical Face Mask is a medical device manufactured by Phu Bao Group Company Limited. It received FDA 510(k) clearance on 2022-09-02 under approval number K222426. 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 Perfetta Moderate Medical Face Mask?

Perfetta Moderate Medical Face Mask is a medical device that received FDA 510(k) clearance on 2022-09-02. It is manufactured by Phu Bao Group Company Limited. The 510(k) number is K222426.

When was Perfetta Moderate Medical Face Mask approved by the FDA?

Perfetta Moderate Medical Face Mask received FDA 510(k) clearance on 2022-09-02, under approval number K222426.

What company makes Perfetta Moderate Medical Face Mask?

Perfetta Moderate Medical Face Mask is manufactured by Phu Bao Group Company Limited.

What is the FDA product code for Perfetta Moderate Medical Face Mask?

The FDA product code for Perfetta Moderate Medical Face Mask is FXX.

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Related PubMed Literature

PMID: 39949844 Protocol for a usability and pilot implementation study of a digital medical device to assess pain in non-verbal people with dementia in Portuguese residential care facilities. Digital health (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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