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FDA 510(k)

Allura Xper FD series and Allura Xper OR Table series

K-Number: K161563 · 2016-07-29

ApplicantPhilips Medical Systems Nederland B.V.
Decision Date2016-07-29
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Allura Xper FD series and Allura Xper OR Table series is a medical device manufactured by Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2016-07-29 under approval number K161563. 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 FD series and Allura Xper OR Table series?

Allura Xper FD series and Allura Xper OR Table series is a medical device that received FDA 510(k) clearance on 2016-07-29. It is manufactured by Philips Medical Systems Nederland B.V.. The 510(k) number is K161563.

When was Allura Xper FD series and Allura Xper OR Table series approved by the FDA?

Allura Xper FD series and Allura Xper OR Table series received FDA 510(k) clearance on 2016-07-29, under approval number K161563.

What company makes Allura Xper FD series and Allura Xper OR Table series?

Allura Xper FD series and Allura Xper OR Table series is manufactured by Philips Medical Systems Nederland B.V..

What is the FDA product code for Allura Xper FD series and Allura Xper OR Table series?

The FDA product code for Allura Xper FD series and Allura Xper OR Table series 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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