Azurion R2.0
K-Number: K181830 · 2018-08-02
Decision Date2018-08-02
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Azurion R2.0 is a medical device manufactured by Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2018-08-02 under approval number K181830. 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 R2.0?
Azurion R2.0 is a medical device that received FDA 510(k) clearance on 2018-08-02. It is manufactured by Philips Medical Systems Nederland B.V.. The 510(k) number is K181830.
When was Azurion R2.0 approved by the FDA?
Azurion R2.0 received FDA 510(k) clearance on 2018-08-02, under approval number K181830.
What company makes Azurion R2.0?
Azurion R2.0 is manufactured by Philips Medical Systems Nederland B.V..
What is the FDA product code for Azurion R2.0?
The FDA product code for Azurion R2.0 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.