FDA 510(k)

3.0T Air MP M, 3.0T Air MP L

N.º K: K182504 · 2018-10-12

SolicitanteGe Healthcare Coils (Usa Instruments, Inc.)

Fecha de decisión2018-10-12

Código de productoMOS

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

3.0T Air MP M, 3.0T Air MP L is the device name listed in this FDA 510(k) record. The listed applicant is Ge Healthcare Coils (Usa Instruments, Inc.). It received FDA 510(k) clearance on 2018-10-12 under 510(k) number K182504. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the 3.0T Air MP M, 3.0T Air MP L?

3.0T Air MP M, 3.0T Air MP L is a medical device that received FDA 510(k) clearance on 2018-10-12. The listed applicant is Ge Healthcare Coils (Usa Instruments, Inc.). The 510(k) number is K182504.

When did 3.0T Air MP M, 3.0T Air MP L receive FDA 510(k) clearance?

3.0T Air MP M, 3.0T Air MP L received FDA 510(k) clearance on 2018-10-12, under 510(k) number K182504.

Who is the listed applicant for 3.0T Air MP M, 3.0T Air MP L?

The FDA 510(k) record lists Ge Healthcare Coils (Usa Instruments, Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3.0T Air MP M, 3.0T Air MP L?

The FDA product code for 3.0T Air MP M, 3.0T Air MP L is MOS.

Otros registros que enlistan a Ge Healthcare Coils (Usa Instruments, Inc.) 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.

K2537383.0T AIR 32CH HNA K2233783.0T 16ch AIR AA K180666Coil de Cabeza 48CH K172695AIR Anterior Array, AIR Posterior Array K163205Coil de Cabeza 48CH

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Fuente oficial

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