Azurion R2.1

Interventional Fluoroscopic X-ray System

Philips Medical Systems Nederland BV

The following data is part of a premarket notification filed by Philips Medical Systems Nederland Bv with the FDA for Azurion R2.1.

Pre-market Notification Details

Device IDK200917
510k NumberK200917
Device Name:Azurion R2.1
ClassificationInterventional Fluoroscopic X-ray System
Applicant Philips Medical Systems Nederland BV Veenpluis 4-6 Best,  NL 5684pc
ContactMichelle Campbell
CorrespondentMichelle Campbell
Philips Medical Systems Nederland BV Veenpluis 4-6 Best,  NL 5684pc
Product CodeOWB  
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-06
Decision Date2020-05-01

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