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FDA 510(k)

Aurelia Surgical Mask ASTM Level-3 (2130)

K-Number: K242502 · 2024-11-12

ApplicantSupermax Healthcare Canada – Supermax Medical
Decision Date2024-11-12
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Aurelia Surgical Mask ASTM Level-3 (2130) is a medical device manufactured by Supermax Healthcare Canada – Supermax Medical. It received FDA 510(k) clearance on 2024-11-12 under approval number K242502. 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 Aurelia Surgical Mask ASTM Level-3 (2130)?

Aurelia Surgical Mask ASTM Level-3 (2130) is a medical device that received FDA 510(k) clearance on 2024-11-12. It is manufactured by Supermax Healthcare Canada – Supermax Medical. The 510(k) number is K242502.

When was Aurelia Surgical Mask ASTM Level-3 (2130) approved by the FDA?

Aurelia Surgical Mask ASTM Level-3 (2130) received FDA 510(k) clearance on 2024-11-12, under approval number K242502.

What company makes Aurelia Surgical Mask ASTM Level-3 (2130)?

Aurelia Surgical Mask ASTM Level-3 (2130) is manufactured by Supermax Healthcare Canada – Supermax Medical.

What is the FDA product code for Aurelia Surgical Mask ASTM Level-3 (2130)?

The FDA product code for Aurelia Surgical Mask ASTM Level-3 (2130) 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)

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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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