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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name device, fertility diagnostic, proceptive
510(k) Number K200163
Device Name Ava Fertility Tracker
Applicant
Ava AG
Gustrasse 73
Zurich,  CH 8055
Applicant Contact Blathnaid Feldman
Correspondent
Ava AG
Gustrasse 73
Zurich,  CH 8055
Correspondent Contact Blathnaid Feldman
Classification Product Code
LHD  
Date Received01/22/2020
Decision Date 01/19/2021
Decision Substantially Equivalent (SESE)
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Clinical Trials NCT03161873
Reviewed by Third Party No
Combination Product No
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