K130002 is an FDA 510(k) clearance for the SURECALL LABOR MONITOR. This device is classified as a Uterine Electromyographic Monitor (Class II - Special Controls, product code OSP).
Submitted by Reproductive Research Technologies, LP (Houston, US). The FDA issued a Cleared decision on June 28, 2013, 177 days after receiving the submission on January 2, 2013.
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 | K130002 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 02, 2013 |
| Decision Date | June 28, 2013 |
| Days to Decision | 177 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. |