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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 K210025
Device Name INVU by Nuvo
Applicant
Nuvo- Group , Ltd.
Yigal Alon 94. St., Alon Tower 1
Tel Aviv,  IL 6789155
Applicant Contact Chen Rubinstein
Correspondent
Hogan Lovells US LLP
1735 Market St.
23rd Floor
Philadelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number884.2730
Classification Product Code
LQK  
Date Received01/04/2021
Decision Date 05/28/2021
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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