FDA 510(k)

Ross Ru Wound Dressing Gel

Número K: K162017 · 2017-04-20

Data da decisão2017-04-20

Código do produtoFRO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Ross Ru Wound Dressing Gel is the device name listed in this FDA 510(k) record. The listed applicant is Biotd S.A.. It received FDA 510(k) clearance on 2017-04-20 under 510(k) number K162017. 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.

Perguntas frequentes

What is the Ross Ru Wound Dressing Gel?

Ross Ru Wound Dressing Gel is a medical device that received FDA 510(k) clearance on 2017-04-20. The listed applicant is Biotd S.A.. The 510(k) number is K162017.

When did Ross Ru Wound Dressing Gel receive FDA 510(k) clearance?

Ross Ru Wound Dressing Gel received FDA 510(k) clearance on 2017-04-20, under 510(k) number K162017.

Who is the listed applicant for Ross Ru Wound Dressing Gel?

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

What is the FDA product code for Ross Ru Wound Dressing Gel?

The FDA product code for Ross Ru Wound Dressing Gel is FRO. This falls under the Anesthesiology category.

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