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FDA 510(k)

LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)

N.º K: K172011 · 2018-06-14

SolicitanteHmicro, Inc.
Fecha de decisión2018-06-14
Código de productoDRG
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System) is the device name listed in this FDA 510(k) record. The listed applicant is Hmicro, Inc.. It received FDA 510(k) clearance on 2018-06-14 under 510(k) number K172011. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)?

LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System) is a medical device that received FDA 510(k) clearance on 2018-06-14. The listed applicant is Hmicro, Inc.. The 510(k) number is K172011.

When did LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System) receive FDA 510(k) clearance?

LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System) received FDA 510(k) clearance on 2018-06-14, under 510(k) number K172011.

Who is the listed applicant for LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)?

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

What is the FDA product code for LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)?

The FDA product code for LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System) is DRG.

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Dispositivos relacionados (Código: DRG)

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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