510(k) K140862
K140862 is an FDA 510(k) premarket notification submitted by Monica Healthcare, Ltd. for the device "MONICA NOVII WIRELESS PATCH SYSTEM". The FDA issued a decision of Substantially Equivalent on August 27, 2014. The device falls under product code OSP (Uterine Electromyographic Monitor), a Class II device regulated under 21 CFR 884.2720. Monica Healthcare, Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 27, 2014
- Date Received
- April 3, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Uterine Electromyographic Monitor
- Device Class
- Class II
- Regulation Number
- 884.2720
- Review Panel
- OB
- Submission Type
The uterine electromyographic monitor is intended to pick up uterine emg signals from surface electrodes placed on the maternal abdomen. It produces a uterine activity tracing and monitors women in labor at term gestation with a singleton pregnancy.