510(k) K143114
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 10, 2015
- Date Received
- October 30, 2014
- 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