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FDA 510(k)

Microlyte Ag/Lidocaine

N.º K: K211943 · 2024-10-17

SolicitanteImbed Biosciences
Fecha de decisión2024-10-17
Código de productoFRO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Microlyte Ag/Lidocaine is the device name listed in this FDA 510(k) record. The listed applicant is Imbed Biosciences. It received FDA 510(k) clearance on 2024-10-17 under 510(k) number K211943. 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.

Preguntas frecuentes

What is the Microlyte Ag/Lidocaine?

Microlyte Ag/Lidocaine is a medical device that received FDA 510(k) clearance on 2024-10-17. The listed applicant is Imbed Biosciences. The 510(k) number is K211943.

When did Microlyte Ag/Lidocaine receive FDA 510(k) clearance?

Microlyte Ag/Lidocaine received FDA 510(k) clearance on 2024-10-17, under 510(k) number K211943.

Who is the listed applicant for Microlyte Ag/Lidocaine?

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

What is the FDA product code for Microlyte Ag/Lidocaine?

The FDA product code for Microlyte Ag/Lidocaine is FRO. This falls under the Anesthesiology category.

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Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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