510(k) K253673
K253673 is an FDA 510(k) premarket notification submitted by Marani Health, Inc. for the device "Mcare System (MW-20)". The FDA issued a decision of Substantially Equivalent on Sep 3, 2026. The device falls under product code LQK (Home Uterine Activity Monitor), a Class II device regulated under 21 CFR 884.2730.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 3, 2026
- Date Received
- Nov 21, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Home Uterine Activity Monitor
- Device Class
- Class II
- Regulation Number
- 884.2730
- Review Panel
- OB
- Submission Type