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FDA 510(k)

higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing)

N.º K: K172739 · 2017-10-10

SolicitanteHigi Sh, LLC
Fecha de decisión2017-10-10
Código de productoDXN
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing) is the device name listed in this FDA 510(k) record. The listed applicant is Higi Sh, LLC. It received FDA 510(k) clearance on 2017-10-10 under 510(k) number K172739. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing)?

higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing) is a medical device that received FDA 510(k) clearance on 2017-10-10. The listed applicant is Higi Sh, LLC. The 510(k) number is K172739.

When did higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing) receive FDA 510(k) clearance?

higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing) received FDA 510(k) clearance on 2017-10-10, under 510(k) number K172739.

Who is the listed applicant for higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing)?

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

What is the FDA product code for higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing)?

The FDA product code for higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing) is DXN.

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Fuente oficial

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