FDA 510(k)

Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)

N.º K: K232314 · 2023-09-01

SolicitanteFUJIFILM Healthcare Americas Corporation

Fecha de decisión2023-09-01

Código de productoFDS

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) is the device name listed in this FDA 510(k) record. The listed applicant is FUJIFILM Healthcare Americas Corporation. It received FDA 510(k) clearance on 2023-09-01 under 510(k) number K232314. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)?

Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) is a medical device that received FDA 510(k) clearance on 2023-09-01. The listed applicant is FUJIFILM Healthcare Americas Corporation. The 510(k) number is K232314.

When did Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) receive FDA 510(k) clearance?

Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) received FDA 510(k) clearance on 2023-09-01, under 510(k) number K232314.

Who is the listed applicant for Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)?

The FDA 510(k) record lists FUJIFILM Healthcare Americas Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)?

The FDA product code for Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) is FDS.

Otros registros que enlistan a FUJIFILM Healthcare Americas Corporation como solicitante

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.

K261713Synapse PACS (7.6.0)K251204FUJIFILM Stiffening Wire Device (SW-2000)K243647Synapse PACS (7.5)K233321Double Balloon Endoscope EN-840T, Over-tube TS-1214C K233629Sistema de RM de Lucent APERTO K233687ECHELON Synergy V10.0

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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.