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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)

K-Number: K172739 · 2017-10-10

ApplicantHigi Sh, LLC
Decision Date2017-10-10
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Higi Sh, LLC. The 510(k) number is K172739.

When was higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing) approved by the FDA?

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 approval number K172739.

What company makes 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 manufactured by Higi Sh, LLC.

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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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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