The following data is part of a premarket notification filed by Reproductive Research Technologies, Lp with the FDA for Surecall Labor Monitor.
| Device ID | K130002 |
| 510k Number | K130002 |
| Device Name: | SURECALL LABOR MONITOR |
| Classification | Uterine Electromyographic Monitor |
| Applicant | REPRODUCTIVE RESEARCH TECHNOLOGIES, LP 1770 ST. JAMES, STE 600 Houston, TX 77056 -3433 |
| Contact | J. Harvey Knauss |
| Correspondent | J. Harvey Knauss REPRODUCTIVE RESEARCH TECHNOLOGIES, LP 1770 ST. JAMES, STE 600 Houston, TX 77056 -3433 |
| Product Code | OSP |
| CFR Regulation Number | 884.2720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-02 |
| Decision Date | 2013-06-28 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SURECALL LABOR MONITOR 77464858 3599972 Dead/Cancelled |
Jack N. McCrary 2008-05-02 |