Allura Xper R9
K-Number: K163715 · 2017-01-26
Decision Date2017-01-26
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Allura Xper R9 is a medical device manufactured by Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2017-01-26 under approval 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. It is manufactured by Philips Medical Systems Nederland B.V.. The 510(k) number is K163715.
When was Allura Xper R9 approved by the FDA?
Allura Xper R9 received FDA 510(k) clearance on 2017-01-26, under approval number K163715.
What company makes Allura Xper R9?
Allura Xper R9 is manufactured by Philips Medical Systems Nederland B.V..
What is the FDA product code for Allura Xper R9?
The FDA product code for Allura Xper R9 is OWB.
Other Devices by Philips Medical Systems Nederland B.V.
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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.