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FDA 510(k)

iHealth Align Gluco-Monitoring system

N.º K: K153286 · 2016-08-19

SolicitanteAndon Health Co, Ltd.
Fecha de decisión2016-08-19
Código de productoNBW
Comité asesorCH
DecisiónSubstantially Equivalent

Resumen del dispositivo

iHealth Align Gluco-Monitoring system is the device name listed in this FDA 510(k) record. The listed applicant is Andon Health Co, Ltd.. It received FDA 510(k) clearance on 2016-08-19 under 510(k) number K153286. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the iHealth Align Gluco-Monitoring system?

iHealth Align Gluco-Monitoring system is a medical device that received FDA 510(k) clearance on 2016-08-19. The listed applicant is Andon Health Co, Ltd.. The 510(k) number is K153286.

When did iHealth Align Gluco-Monitoring system receive FDA 510(k) clearance?

iHealth Align Gluco-Monitoring system received FDA 510(k) clearance on 2016-08-19, under 510(k) number K153286.

Who is the listed applicant for iHealth Align Gluco-Monitoring system?

The FDA 510(k) record lists Andon Health Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iHealth Align Gluco-Monitoring system?

The FDA product code for iHealth Align Gluco-Monitoring system is NBW. This falls under the OB/GYN category.

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Fuente oficial

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