Reusable Guides Ranges (PERINE Range, NAIL Range, CON-LEAD Range And LIN-LEAD Range) And STEADY PRO Range

Transducer, Ultrasonic, Diagnostic

Koelis

The following data is part of a premarket notification filed by Koelis with the FDA for Reusable Guides Ranges (perine Range, Nail Range, Con-lead Range And Lin-lead Range) And Steady Pro Range.

Pre-market Notification Details

Device IDK171040
510k NumberK171040
Device Name:Reusable Guides Ranges (PERINE Range, NAIL Range, CON-LEAD Range And LIN-LEAD Range) And STEADY PRO Range
ClassificationTransducer, Ultrasonic, Diagnostic
Applicant Koelis 16, Chemin Du Vieux Chene Meylan,  FR 38240
ContactLaetitia Gervais
CorrespondentLaetitia Gervais
Koelis 16, Chemin Du Vieux Chene Meylan,  FR 38240
Product CodeITX  
CFR Regulation Number892.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-04-06
Decision Date2017-07-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03665134000202 K171040 000
03665134000189 K171040 000
03665134000301 K171040 000
03665134000318 K171040 000
03665134000158 K171040 000
03665134000325 K171040 000
03665134000738 K171040 000
03665134000745 K171040 000
03665134000783 K171040 000
03665134000806 K171040 000
03665134000110 K171040 000
03665134000172 K171040 000
03665134000141 K171040 000
03665134000134 K171040 000
03665134000936 K171040 000

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