510(k) K190798
K190798 is an FDA 510(k) premarket notification submitted by Obmedical Company for the device "LaborView LV1000 Wireless Electrode System". The FDA issued a decision of Substantially Equivalent on September 18, 2020. The device falls under product code OSP (Uterine Electromyographic Monitor), a Class II device regulated under 21 CFR 884.2720. Obmedical Company has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 18, 2020
- Date Received
- March 28, 2019
- 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.