FDA 510(k)

Allura Xper R9

K-Number: K162148 · 2016-11-23

ApplicantPhilips Medical Systems Nethrlands BV

Decision Date2016-11-23

Product CodeOWB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Allura Xper R9 is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nethrlands BV. It received FDA 510(k) clearance on 2016-11-23 under 510(k) number K162148. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Allura Xper R9?

Allura Xper R9 is a medical device that received FDA 510(k) clearance on 2016-11-23. The listed applicant is Philips Medical Systems Nethrlands BV. The 510(k) number is K162148.

When did Allura Xper R9 receive FDA 510(k) clearance?

Allura Xper R9 received FDA 510(k) clearance on 2016-11-23, under 510(k) number K162148.

Who is the listed applicant for Allura Xper R9?

The FDA 510(k) record lists Philips Medical Systems Nethrlands BV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Allura Xper R9?

The FDA product code for Allura Xper R9 is OWB.

Related Devices (Code: OWB)

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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.