LQK — Home Uterine Activity Monitor Class II
FDA product code LQK covers "Home Uterine Activity Monitor", a Class II medical device regulated under 21 CFR 884.2730. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LQK
- Device Class
- Class II
- Regulation Number
- 884.2730
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253673 | Marani Health | Mcare System (MW-20) | Sep 3, 2026 |
| K221046 | Nuvo- Group | Invu by Nuvo | May 6, 2022 |
| K210025 | Nuvo- Group | INVU by Nuvo | May 28, 2021 |
| K191401 | Nuvo- Group | PregSense | Mar 27, 2020 |
| K143114 | Airstrip Technologies | Sense4Baby System Model B+ (MSA) | Mar 10, 2015 |
| K020390 | Huntleigh Diagnostics | MODIFICATION TO FETAL ASSIST | Apr 19, 2002 |