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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name home uterine activity monitor
510(k) Number K191401
Device Name PregSense
Applicant
Nuvo-Group Ltd.
Yigal Alon 94. St, Alon Tower 1
Tel Aviv,  IL 6789155
Applicant Contact Adar Shani
Correspondent
Hogan Lovells US LLP
1735 Market St., 23rd Fl.
Philadelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number884.2730
Classification Product Code
LQK  
Date Received05/24/2019
Decision Date 03/27/2020
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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