The following data is part of a premarket notification filed by Reproductive Research Technologies, Lp with the FDA for Surecall Emg Labor Monitor.
| Device ID | K090145 |
| 510k Number | K090145 |
| Device Name: | SURECALL EMG LABOR MONITOR |
| Classification | Uterine Electromyographic Monitor |
| Applicant | REPRODUCTIVE RESEARCH TECHNOLOGIES, LP 11874 SOUTH EVELYN Houston, TX 77071 |
| Contact | J. Harvey Knauss |
| Correspondent | J. Harvey Knauss REPRODUCTIVE RESEARCH TECHNOLOGIES, LP 11874 SOUTH EVELYN Houston, TX 77071 |
| Product Code | OSP |
| CFR Regulation Number | 884.2720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-21 |
| Decision Date | 2011-01-25 |
| Summary: | summary |