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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colposcope (And Colpomicroscope)
510(k) Number K161871
Device Name EVA (Enhanced Visual Assessment) System
Applicant
Mobileodt , Ltd.
41 Gershon Shatz St., 2nd Floor
Tel Aviv,  IL 6701779
Applicant Contact Jen Acobas
Correspondent
Mobileodt , Ltd.
Ben Avigdor 8
3rd Floor
Tel Aviv,  IL 6721832
Correspondent Contact Jen Acobas
Regulation Number884.1630
Classification Product Code
HEX  
Date Received07/07/2016
Decision Date 12/19/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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