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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K180970
Device Name Disposable guides KDNG00
Applicant
Koelis
16, Chemin Du Vieux Chene
Meylan,  FR 38240
Applicant Contact Pauline Nicole
Correspondent
Koelis
16, Chemin Du Vieux Chene
Meylan,  FR 38240
Correspondent Contact Pauline Nicole
Regulation Number892.1570
Classification Product Code
ITX  
Date Received04/13/2018
Decision Date 07/10/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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