FDA 510(k)

Derma-R Cream (Derma-R Cream)

Numéro K : K240722 · 2024-09-20

Date de décision2024-09-20

Code produitFRO

DécisionSubstantially Equivalent

Résumé du dispositif

Derma-R Cream (Derma-R Cream) is the device name listed in this FDA 510(k) record. The listed applicant is Raya Pharmaceuticals, LLC. It received FDA 510(k) clearance on 2024-09-20 under 510(k) number K240722. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Derma-R Cream (Derma-R Cream)?

Derma-R Cream (Derma-R Cream) is a medical device that received FDA 510(k) clearance on 2024-09-20. The listed applicant is Raya Pharmaceuticals, LLC. The 510(k) number is K240722.

When did Derma-R Cream (Derma-R Cream) receive FDA 510(k) clearance?

Derma-R Cream (Derma-R Cream) received FDA 510(k) clearance on 2024-09-20, under 510(k) number K240722.

Who is the listed applicant for Derma-R Cream (Derma-R Cream)?

The FDA 510(k) record lists Raya Pharmaceuticals, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Derma-R Cream (Derma-R Cream)?

The FDA product code for Derma-R Cream (Derma-R Cream) is FRO. This falls under the Anesthesiology category.

Essais cliniques associés

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Dispositifs connexes (Code : FRO)

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Source officielle

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