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FDA 510(k)

Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)

Número K: K180305 · 2018-04-13

RequerenteAquilabs Us, LLC
Data da decisão2018-04-13
Código do produtoFRO
DecisãoSubstantially Equivalent

Resumo do dispositivo

Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) is the device name listed in this FDA 510(k) record. The listed applicant is Aquilabs Us, LLC. It received FDA 510(k) clearance on 2018-04-13 under 510(k) number K180305. 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 Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)?

Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) is a medical device that received FDA 510(k) clearance on 2018-04-13. The listed applicant is Aquilabs Us, LLC. The 510(k) number is K180305.

When did Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) receive FDA 510(k) clearance?

Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) received FDA 510(k) clearance on 2018-04-13, under 510(k) number K180305.

Who is the listed applicant for Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)?

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

What is the FDA product code for Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)?

The FDA product code for Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) is FRO. This falls under the Anesthesiology category.

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