FDA 510(k)

INVOcell Intravaginal Culture System

Numéro K : K222932 · 2023-06-22

Date de décision2023-06-22

Code produitOYO

Comité consultatifOB

DécisionSubstantially Equivalent

Résumé du dispositif

INVOcell Intravaginal Culture System is the device name listed in this FDA 510(k) record. The listed applicant is Invo Bioscience. It received FDA 510(k) clearance on 2023-06-22 under 510(k) number K222932. The device is classified under product code OYO. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the INVOcell Intravaginal Culture System?

INVOcell Intravaginal Culture System is a medical device that received FDA 510(k) clearance on 2023-06-22. The listed applicant is Invo Bioscience. The 510(k) number is K222932.

When did INVOcell Intravaginal Culture System receive FDA 510(k) clearance?

INVOcell Intravaginal Culture System received FDA 510(k) clearance on 2023-06-22, under 510(k) number K222932.

Who is the listed applicant for INVOcell Intravaginal Culture System?

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

What is the FDA product code for INVOcell Intravaginal Culture System?

The FDA product code for INVOcell Intravaginal Culture System is OYO.

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Source officielle

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