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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
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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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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