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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
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