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FDA 510(k)

PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor

K-Number: K181292 · 2018-11-15

ApplicantCogentix Medical, Inc.
Decision Date2018-11-15
Product CodeEOX
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor is a medical device manufactured by Cogentix Medical, Inc.. It received FDA 510(k) clearance on 2018-11-15 under approval number K181292. The device is classified under product code EOX. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor?

PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor is a medical device that received FDA 510(k) clearance on 2018-11-15. It is manufactured by Cogentix Medical, Inc.. The 510(k) number is K181292.

When was PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor approved by the FDA?

PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor received FDA 510(k) clearance on 2018-11-15, under approval number K181292.

What company makes PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor?

PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor is manufactured by Cogentix Medical, Inc..

What is the FDA product code for PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor?

The FDA product code for PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor is EOX.

Other Devices by Cogentix Medical, Inc.

K253905PrimeSight UltraView System

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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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