PregSense— 510(k) K191401

Substantially Equivalent

Nuvo- Group , Ltd.

FDA 510(k) clearance K191401 for PregSense, Substantially Equivalent on 2020-03-27. Applicant: Nuvo- Group , Ltd..

Clearance details

Applicant: Nuvo- Group , Ltd.
Product code: Code LQK
Advisory panel: Obstetrics/Gynecology
Date received: 2019-05-24
Decision date: 2020-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tel Aviv, IL

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