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FDA 510(k)

AMBARINO High-Class

K-Number: K222723 · 2022-09-09

Decision Date2022-09-09
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the AMBARINO High-Class?

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

When was AMBARINO High-Class approved by the FDA?

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

What company makes AMBARINO High-Class?

AMBARINO High-Class is manufactured by Creamed GmbH & Co. Produktions- Und Handels KG.

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

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

Related Devices (Code: EBF)

Official Source

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