PregSense
Home Uterine Activity Monitor
Nuvo-Group Ltd.
The following data is part of a premarket notification filed by Nuvo-group Ltd. with the FDA for Pregsense.
Pre-market Notification Details
| Device ID | K191401 |
| 510k Number | K191401 |
| Device Name: | PregSense |
| Classification | Home Uterine Activity Monitor |
| Applicant | Nuvo-Group Ltd. Yigal Alon 94. St, Alon Tower 1 Tel Aviv, IL 6789155 |
| Contact | Adar Shani |
| Correspondent | Janice Hogan Hogan Lovells US LLP 1735 Market St., 23rd Fl. Philadelphia, PA 19103 |
| Product Code | LQK |
| CFR Regulation Number | 884.2730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-24 |
| Decision Date | 2020-03-27 |
Trademark Results [PregSense]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PREGSENSE 79179133 5038544 Live/Registered |
NUVO GROUP LTD 2015-07-12 |
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