TRINITY/3D PROSTATE SUITE

System, Imaging, Pulsed Doppler, Ultrasonic

KOELIS

The following data is part of a premarket notification filed by Koelis with the FDA for Trinity/3d Prostate Suite.

Pre-market Notification Details

Device IDK170521
510k NumberK170521
Device Name:TRINITY/3D PROSTATE SUITE
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant KOELIS 16, Chemin Du Vieux Chene Meylan,  FR 38240
ContactLaetitia Gervais
CorrespondentLaetitia Gervais
KOELIS 16, Chemin Du Vieux Chene Meylan,  FR 38240
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
Subsequent Product CodeLLZ
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-02-22
Decision Date2017-05-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03665134000691 K170521 000
03665134000714 K170521 000
03665134000530 K170521 000
03665134000523 K170521 000
03665134000516 K170521 000
03665134000509 K170521 000
03665134000929 K170521 000
03665134000851 K170521 000

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