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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 the device name listed in this FDA 510(k) record. The listed applicant is Orfit Industries NV. It received FDA 510(k) clearance on 2017-07-25 under 510(k) 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. The listed applicant is Orfit Industries NV. The 510(k) number is K171734.

When did HP PRO Positioning Device receive FDA 510(k) clearance?

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

Who is the listed applicant for HP PRO Positioning Device?

The FDA 510(k) record lists Orfit Industries NV as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Orfit Industries NV as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: 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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