FDA 510(k)

AMBARINO High-Class

Numéro K : K222723 · 2022-09-09

DemandeurCreamed GmbH & Co. Produktions- Und Handels KG

Date de décision2022-09-09

Code produitEBF

Comité consultatifDE

DécisionSubstantially Equivalent

Résumé du dispositif

AMBARINO High-Class is the device name listed in this FDA 510(k) record. The listed applicant is Creamed GmbH & Co. Produktions- Und Handels KG. It received FDA 510(k) clearance on 2022-09-09 under 510(k) number K222723. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the AMBARINO High-Class?

AMBARINO High-Class is a medical device that received FDA 510(k) clearance on 2022-09-09. The listed applicant is Creamed GmbH & Co. Produktions- Und Handels KG. The 510(k) number is K222723.

When did AMBARINO High-Class receive FDA 510(k) clearance?

AMBARINO High-Class received FDA 510(k) clearance on 2022-09-09, under 510(k) number K222723.

Who is the listed applicant for AMBARINO High-Class?

The FDA 510(k) record lists Creamed GmbH & Co. Produktions- Und Handels KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMBARINO High-Class?

The FDA product code for AMBARINO High-Class is EBF.

Essais cliniques associés

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Source officielle

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