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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Esophagoscope (Flexible Or Rigid)
510(k) Number K181292
Device Name PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor
Applicant
Cogentix Medical, Inc.
40 Ramland Rd. S.
Orangeburg,  NY  10962
Applicant Contact Christa Blaisdell
Correspondent
Cogentix Medical, Inc.
40 Ramland Rd. S.
Orangeburg,  NY  10962
Correspondent Contact Christa Blaisdell
Regulation Number874.4710
Classification Product Code
EOX  
Subsequent Product Codes
EOB   EOQ   FAJ   OCS  
Date Received05/16/2018
Decision Date 11/15/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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