510(k) K210025
- Device
- INVU By Nuvo
- Applicant
- Nuvo-Group Ltd.
- 510(k) number
- K210025
- Product code
- LQK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-05-28
- Date received
- 2021-01-04
- Regulation
- 884.2730
- Classification name
- Home Uterine Activity Monitor
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Chen Rubinstein
- Address
- Yigal Alon 94. St., Alon Tower 1 Tel Aviv IL 6789155 6789155
FDA Registration Numbers#
- 3016829704
- 3010032952
Source Documents#
Other 510(k) Records For Product Code LQK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K221046 | Invu by Nuvo | Nuvo- Group , Ltd. | 2022-05-06 |
| K191401 | PregSense | Nuvo- Group , Ltd. | 2020-03-27 |
| K143114 | Sense4Baby System Model B+ (MSA) | Airstrip Technologies, Inc. | 2015-03-10 |
| K020390 | MODIFICATION TO FETAL ASSIST | Huntleigh Diagnostics , Ltd. | 2002-04-19 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases