ECHONAVIGATOR RELEASE 1

System, Image Processing, Radiological

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 Echonavigator Release 1.

Pre-market Notification Details

Device IDK121781
510k NumberK121781
Device Name:ECHONAVIGATOR RELEASE 1
ClassificationSystem, Image Processing, Radiological
Applicant PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. VEENPLUIS 4-6 Best,  NL 5684 Pc
ContactFrans Jacobs
CorrespondentFrans Jacobs
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. VEENPLUIS 4-6 Best,  NL 5684 Pc
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-06-18
Decision Date2012-10-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838080737 K121781 000
00884838059283 K121781 000
00884838106437 K121781 000

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