510(k) K253673
- Device
- M•care System (MW-20)
- Applicant
- Marani Health, Inc.
- 510(k) number
- K253673
- Product code
- LQK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-09-03
- Date received
- 2025-11-21
- 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
- N
Applicant Contact#
- Contact
- Mindy A. Ditch
- Address
- 3510 Hopkins Pl. N. Oakdale MN US 55128 55128
FDA Registration Numbers#
- 3010032952
- 3016829704
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 |
| K210025 | INVU by Nuvo | Nuvo- Group , Ltd. | 2021-05-28 |
| 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 |