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FDA 510(k)

Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2

K-Number: K231005 · 2023-12-05

ApplicantSupermax Healthcare Canada-Supermax Medical
Decision Date2023-12-05
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2 is a medical device manufactured by Supermax Healthcare Canada-Supermax Medical. It received FDA 510(k) clearance on 2023-12-05 under approval number K231005. 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 1; Aurelia Surgical Mask ASTM Level 2?

Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2 is a medical device that received FDA 510(k) clearance on 2023-12-05. It is manufactured by Supermax Healthcare Canada-Supermax Medical. The 510(k) number is K231005.

When was Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2 approved by the FDA?

Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2 received FDA 510(k) clearance on 2023-12-05, under approval number K231005.

What company makes Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2?

Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2 is manufactured by Supermax Healthcare Canada-Supermax Medical.

What is the FDA product code for Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2?

The FDA product code for Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2 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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