510(k) clearance
M•care System (MW-20)
- 510(k) number
- K253673
- Applicant
- Marani Health, Inc.
- Decision date
- Sep 3, 2026
- Date received
- Nov 21, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- LQK
- Device type
- Home Uterine Activity Monitor
- Device class
- Class II
- Regulation
- 21 CFR 884.2730
- Advisory committee
- Obstetrics/Gynecology
- Statement or summary
- Summary
- Third party
- N
- Location
- Oakdale, MN, US