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FDA 510(k)

Silverlon Wound Contact, Burn Contact Dressings

N.º K: K221218 · 2022-10-26

SolicitanteArgentum Medical, Inc.
Fecha de decisión2022-10-26
Código de productoFRO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Silverlon Wound Contact, Burn Contact Dressings is the device name listed in this FDA 510(k) record. The listed applicant is Argentum Medical, Inc.. It received FDA 510(k) clearance on 2022-10-26 under 510(k) number K221218. 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 Silverlon Wound Contact, Burn Contact Dressings?

Silverlon Wound Contact, Burn Contact Dressings is a medical device that received FDA 510(k) clearance on 2022-10-26. The listed applicant is Argentum Medical, Inc.. The 510(k) number is K221218.

When did Silverlon Wound Contact, Burn Contact Dressings receive FDA 510(k) clearance?

Silverlon Wound Contact, Burn Contact Dressings received FDA 510(k) clearance on 2022-10-26, under 510(k) number K221218.

Who is the listed applicant for Silverlon Wound Contact, Burn Contact Dressings?

The FDA 510(k) record lists Argentum Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Silverlon Wound Contact, Burn Contact Dressings?

The FDA product code for Silverlon Wound Contact, Burn Contact Dressings is FRO. This falls under the Anesthesiology category.

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Dispositivos relacionados (Código: FRO)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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Fuente oficial

Ver en la base de datos de la FDA →

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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