HEARTNAVIGATOR RELEASE 2.0

Interventional Fluoroscopic X-ray System

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

The following data is part of a premarket notification filed by Philips Medical Systems Nederland B.v. with the FDA for Heartnavigator Release 2.0.

Pre-market Notification Details

Device IDK140138
510k NumberK140138
Device Name:HEARTNAVIGATOR RELEASE 2.0
ClassificationInterventional Fluoroscopic X-ray System
Applicant PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 3959 VAN DYKE ROAD, SUITE 245 Lutz,  FL  33558
ContactMichael Dayton
CorrespondentMichael Dayton
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 3959 VAN DYKE ROAD, SUITE 245 Lutz,  FL  33558
Product CodeOWB  
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-01-22
Decision Date2014-06-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838080744 K140138 000
00884838059207 K140138 000

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