Panels › Obstetrics/Gynecology › Product code LQK · Class 2
Home Uterine Activity Monitor
Regulation 884.2730
1510(k)s in 12 months (6 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in LQK
| Company | 510(k)s | Recalls |
|---|---|---|
| Nuvo- Group , Ltd. | 3 | 0 |
| Airstrip Technologies, Inc. | 1 | 1 |
| Huntleigh Diagnostics , Ltd. | 1 | 0 |
| Marani Health, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 3, 2026 | K253673 | Mcare System (MW-20) Marani Health, Inc. | LQK |
| May 6, 2022 | K221046 | Invu by Nuvo Nuvo- Group , Ltd., IL | LQK |
| May 28, 2021 | K210025 | INVU by Nuvo Nuvo- Group , Ltd., IL | LQK |
| Mar 27, 2020 | K191401 | PregSense Nuvo- Group , Ltd., IL | LQK |
| Mar 10, 2015 | K143114 | Sense4Baby System Model B+ (MSA) Airstrip Technologies, Inc. | LQK |
| Apr 19, 2002 | K020390 | MODIFICATION TO FETAL ASSIST Huntleigh Diagnostics , Ltd. | LQK |
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