K153262 is an FDA 510(k) clearance for the PUREtrace?. This device is classified as a Uterine Electromyographic Monitor (Class II - Special Controls, product code OSP).
Submitted by Nemo Healthcare BV (Veldhoven, NL). The FDA issued a Cleared decision on February 7, 2017, 455 days after receiving the submission on November 10, 2015.
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 | K153262 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 10, 2015 |
| Decision Date | February 07, 2017 |
| Days to Decision | 455 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. |