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FDA 510(k)

Azurion series R1.2

K-Number: K172822 · 2017-11-22

ApplicantPhilips Medical Systems Nederland B.V.
Decision Date2017-11-22
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Azurion series R1.2 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 2017-11-22 under 510(k) 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. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K172822.

When did Azurion series R1.2 receive FDA 510(k) clearance?

Azurion series R1.2 received FDA 510(k) clearance on 2017-11-22, under 510(k) number K172822.

Who is the listed applicant for Azurion series R1.2?

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 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.

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