The following data is part of a premarket notification filed by Nuvo-group Ltd. with the FDA for Invu By Nuvo.
Device ID | K210025 |
510k Number | K210025 |
Device Name: | INVU By Nuvo |
Classification | Home Uterine Activity Monitor |
Applicant | Nuvo-Group Ltd. Yigal Alon 94. St, Alon Tower 1 Tel Aviv, IL 6789155 |
Contact | Chen Rubinstein |
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 | 2021-01-04 |
Decision Date | 2021-05-28 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
INVU BY NUVO 79292705 not registered Live/Pending |
NUVO GROUP LTD 2020-05-12 |