FDA 510(k), K191401, PregSense

FDA 510(k), K191401, PregSense

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510(K) Number: K191401
Device Name: PregSense
Manufacturer: Nuvo-Group Ltd.
Device Classification Name: home uterine activity monitor
Regulation Number: 884.2730
Classification Product Code: LQK
Date Received: 05/24/2019
Decision Date: 03/27/2020
Regulation Medical Specialty: Obstetrics/Gynecology

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