Azurion series R1.2
K-Number: K172822 · 2017-11-22
Decision Date2017-11-22
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Azurion series R1.2 is a medical device manufactured by Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2017-11-22 under approval number K172822. 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 Azurion series R1.2?
Azurion series R1.2 is a medical device that received FDA 510(k) clearance on 2017-11-22. It is manufactured by Philips Medical Systems Nederland B.V.. The 510(k) number is K172822.
When was Azurion series R1.2 approved by the FDA?
Azurion series R1.2 received FDA 510(k) clearance on 2017-11-22, under approval number K172822.
What company makes Azurion series R1.2?
Azurion series R1.2 is manufactured by Philips Medical Systems Nederland B.V..
What is the FDA product code for Azurion series R1.2?
The FDA product code for Azurion series R1.2 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.