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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K181292

PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor · Cogentix Medical, Inc. · decided 2018-11-15 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
UNITY 9100UVP-9100COGENTIX MEDICAL, INC.EOB EOQ EOX FAJ OCS00874485003210
UNITY 9000UVP-9000COGENTIX MEDICAL, INC.EOB EOQ EOX FAJ OCS00874485003227