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FDA 510(k)

HP PRO Positioning Device

K-Number: K171734 · 2017-07-25

ApplicantOrfit Industries NV
Decision Date2017-07-25
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HP PRO Positioning Device is a medical device manufactured by Orfit Industries NV. It received FDA 510(k) clearance on 2017-07-25 under approval number K171734. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HP PRO Positioning Device?

HP PRO Positioning Device is a medical device that received FDA 510(k) clearance on 2017-07-25. It is manufactured by Orfit Industries NV. The 510(k) number is K171734.

When was HP PRO Positioning Device approved by the FDA?

HP PRO Positioning Device received FDA 510(k) clearance on 2017-07-25, under approval number K171734.

What company makes HP PRO Positioning Device?

HP PRO Positioning Device is manufactured by Orfit Industries NV.

What is the FDA product code for HP PRO Positioning Device?

The FDA product code for HP PRO Positioning Device is IYE.

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Official Source

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

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