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FDA 510(k)

Savvy Surgical Mask - Level 3

K-Number: K230383 · 2023-03-06

ApplicantAlg Health, LLC
Decision Date2023-03-06
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Savvy Surgical Mask - Level 3 is a medical device manufactured by Alg Health, LLC. It received FDA 510(k) clearance on 2023-03-06 under approval number K230383. 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 Savvy Surgical Mask - Level 3?

Savvy Surgical Mask - Level 3 is a medical device that received FDA 510(k) clearance on 2023-03-06. It is manufactured by Alg Health, LLC. The 510(k) number is K230383.

When was Savvy Surgical Mask - Level 3 approved by the FDA?

Savvy Surgical Mask - Level 3 received FDA 510(k) clearance on 2023-03-06, under approval number K230383.

What company makes Savvy Surgical Mask - Level 3?

Savvy Surgical Mask - Level 3 is manufactured by Alg Health, LLC.

What is the FDA product code for Savvy Surgical Mask - Level 3?

The FDA product code for Savvy Surgical Mask - Level 3 is FXX.

Related Clinical Trials

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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026)

Related Devices (Code: FXX)

K153409Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)Protect U Guard, LLC K160269Surgical Face Masks (Ear loops and Tie-on)San-M Package Co., Ltd. K152197Skypro, SP01 MaskSkypro Medical Supplies Company K153496Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd. K152561Communicator Surgical Facemask with Clear WindowPrestige Ameritech , Ltd. K171162Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap ShieldPrestige Ameritech

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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