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FDA 510(k)

MEDAX UNIPERSONALE SRL

K-Number: K092338 · 2011-05-27

ApplicantMedax Unipersonale Srl
Decision Date2011-05-27
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MEDAX UNIPERSONALE SRL is the device name listed in this FDA 510(k) record. The listed applicant is Medax Unipersonale Srl. It received FDA 510(k) clearance on 2011-05-27 under 510(k) number K092338. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDAX UNIPERSONALE SRL?

MEDAX UNIPERSONALE SRL is a medical device that received FDA 510(k) clearance on 2011-05-27. The listed applicant is Medax Unipersonale Srl. The 510(k) number is K092338.

When did MEDAX UNIPERSONALE SRL receive FDA 510(k) clearance?

MEDAX UNIPERSONALE SRL received FDA 510(k) clearance on 2011-05-27, under 510(k) number K092338.

Who is the listed applicant for MEDAX UNIPERSONALE SRL?

The FDA 510(k) record lists Medax Unipersonale Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDAX UNIPERSONALE SRL?

The FDA product code for MEDAX UNIPERSONALE SRL is KNW.

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Official Source

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