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FDA 510(k)

P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil

N.º K: K163661 · 2018-03-21

SolicitanteRapid Biomedical GmbH
Fecha de decisión2018-03-21
Código de productoMOS
Comité asesorRA
DecisiónSubstantially Equivalent

Resumen del dispositivo

P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil is the device name listed in this FDA 510(k) record. The listed applicant is Rapid Biomedical GmbH. It received FDA 510(k) clearance on 2018-03-21 under 510(k) number K163661. 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 P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil?

P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil is a medical device that received FDA 510(k) clearance on 2018-03-21. The listed applicant is Rapid Biomedical GmbH. The 510(k) number is K163661.

When did P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil receive FDA 510(k) clearance?

P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil received FDA 510(k) clearance on 2018-03-21, under 510(k) number K163661.

Who is the listed applicant for P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil?

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

What is the FDA product code for P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil?

The FDA product code for P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil is MOS.

Otros registros que enlistan a Rapid Biomedical GmbH 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.

K21348031P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head CoilK1915391.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil SupportK1819481.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil

Dispositivos relacionados (Código: MOS)

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.

K262330dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0TPhilips Medical Systems Nederland B.V.K262294dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0TPhilips Medical Systems Nederland B.V.K2609470.55T 12Ch Bobina de MamaNeocoil, LLCK252587HD 8Ch Wrist ArrayShenzhen RF Tech Co., Ltd.K252876GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive OnlyShenzhen RF Tech Co., Ltd.K260519Smart Fit TorsoCardiac 1.5TPhilips Healthcare (Suzhou) Co., Ltd.

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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