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FDA 510(k)

TRINITY

K-Number: K160357 · 2016-05-02

ApplicantKoelis
Decision Date2016-05-02
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TRINITY is a medical device manufactured by Koelis. It received FDA 510(k) clearance on 2016-05-02 under approval number K160357. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRINITY?

TRINITY is a medical device that received FDA 510(k) clearance on 2016-05-02. It is manufactured by Koelis. The 510(k) number is K160357.

When was TRINITY approved by the FDA?

TRINITY received FDA 510(k) clearance on 2016-05-02, under approval number K160357.

What company makes TRINITY?

TRINITY is manufactured by Koelis.

What is the FDA product code for TRINITY?

The FDA product code for TRINITY is IYN.

Other Devices by Koelis

K171040Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range K170521TRINITY/3D PROSTATE SUITE K180970Disposable guides KDNG00

Related Devices (Code: IYN)

K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi , Ltd. K163138Clarius Ultrasound SystemClarius Mobile Health Corp. K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics K162583ALOKA LISENDO 880Hitachi , Ltd. K163020Xperius Ultrasound SystemPhilips Health Care

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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