K190798 is an FDA 510(k) clearance for the LaborView? LV1000 Wireless Electrode System. This device is classified as a Uterine Electromyographic Monitor (Class II — Special Controls, product code OSP).
Submitted by Obmedical Company (Gainesville, US). The FDA issued a Cleared decision on September 18, 2020, 540 days after receiving the submission on March 28, 2019.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.2720. 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..
| 510(k) Number | K190798 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 28, 2019 |
| Decision Date | September 18, 2020 |
| Days to Decision | 540 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | OSP — Uterine Electromyographic Monitor |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.2720 |
| Definition | 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. |