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FDA 510(k)

Field Shield Wound Dressing

N.º K: K212521 · 2024-07-18

SolicitanteKericure, Inc.
Fecha de decisión2024-07-18
Código de productoFRO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Field Shield Wound Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Kericure, Inc.. It received FDA 510(k) clearance on 2024-07-18 under 510(k) number K212521. 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 Field Shield Wound Dressing?

Field Shield Wound Dressing is a medical device that received FDA 510(k) clearance on 2024-07-18. The listed applicant is Kericure, Inc.. The 510(k) number is K212521.

When did Field Shield Wound Dressing receive FDA 510(k) clearance?

Field Shield Wound Dressing received FDA 510(k) clearance on 2024-07-18, under 510(k) number K212521.

Who is the listed applicant for Field Shield Wound Dressing?

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

What is the FDA product code for Field Shield Wound Dressing?

The FDA product code for Field Shield Wound Dressing 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

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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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