LQK
5 FDA 510(k) clearances · Product code
131 daysmedian time to decision
308 days90th percentile
5clearances measured
FDA profile
- Official device name
- Home Uterine Activity Monitor
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2730
- Medical specialty
- Obstetrics/Gynecology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Invu by Nuvo (K221046) | Nuvo- Group , Ltd. | 2022-05-06 |
| INVU by Nuvo (K210025) | Nuvo- Group , Ltd. | 2021-05-28 |
| PregSense (K191401) | Nuvo- Group , Ltd. | 2020-03-27 |
| Sense4Baby System Model B+ (MSA) (K143114) | Airstrip Technologies, Inc. | 2015-03-10 |
| MODIFICATION TO FETAL ASSIST (K020390) | Huntleigh Diagnostics , Ltd. | 2002-04-19 |
Track LQK automatically
Every clearance here is in the API, with alerts when new ones post.