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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 K221046
Device Name Invu by Nuvo
Nuvo- Group Ltd.
Yigal Alon 94. St, Alon Tower 1
Tel Aviv,  IL 6789155
Applicant Contact Chen Rubinstein
Hogan Lovells US LLP
1735 Market St., 23rd Floor
Philladelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number884.2730
Classification Product Code
Date Received04/08/2022
Decision Date 05/06/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No