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FDA 510(k)

Allura Xper R9

K-Number: K163715 · 2017-01-26

ApplicantPhilips Medical Systems Nederland B.V.
Decision Date2017-01-26
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 Nederland B.V.. It received FDA 510(k) clearance on 2017-01-26 under 510(k) number K163715. 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 2017-01-26. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K163715.

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

Allura Xper R9 received FDA 510(k) clearance on 2017-01-26, under 510(k) number K163715.

Who is the listed applicant for Allura Xper R9?

The FDA 510(k) record lists Philips Medical Systems Nederland B.V. 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.

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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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