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 |