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FDA 510(k)

F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring

N.º K: K171865 · 2017-08-24

SolicitanteFarus, LLC
Fecha de decisión2017-08-24
Código de productoHGM
Comité asesorOB
DecisiónSubstantially Equivalent

Resumen del dispositivo

F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring is the device name listed in this FDA 510(k) record. The listed applicant is Farus, LLC. It received FDA 510(k) clearance on 2017-08-24 under 510(k) number K171865. The device is classified under product code HGM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring?

F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring is a medical device that received FDA 510(k) clearance on 2017-08-24. The listed applicant is Farus, LLC. The 510(k) number is K171865.

When did F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring receive FDA 510(k) clearance?

F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring received FDA 510(k) clearance on 2017-08-24, under 510(k) number K171865.

Who is the listed applicant for F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring?

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

What is the FDA product code for F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring?

The FDA product code for F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring is HGM.

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Dispositivos relacionados (Código: HGM)

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.

K254036Novii+ Wireless Patch SystemDatex Ohmeda, Inc.K253021ANNE MaternaSibel Health, Inc.K250777Sonicaid Team3Huntleigh Healthcare , Ltd.K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.K241368Sonicaid Team3Huntleigh Healthcare , Ltd.K241009PeriCALM Patterns 3.0Perigen, Inc.

Fuente oficial

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