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FDA 510(k)

Azurion R2.1

K-Number: K200917 · 2020-05-01

ApplicantPhilips Medical Systems Nederland B.V.
Decision Date2020-05-01
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Azurion R2.1 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 2020-05-01 under 510(k) number K200917. 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 R2.1?

Azurion R2.1 is a medical device that received FDA 510(k) clearance on 2020-05-01. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K200917.

When did Azurion R2.1 receive FDA 510(k) clearance?

Azurion R2.1 received FDA 510(k) clearance on 2020-05-01, under 510(k) number K200917.

Who is the listed applicant for Azurion R2.1?

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 Azurion R2.1?

The FDA product code for Azurion R2.1 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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