Clearance Summary
EMTRAC; DELPHIN; SEMTRAC 2000 SET received FDA 510(k) clearance under submission number K013536, sponsored by Gynetics Medical Products NV. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2001-11-30.
- Submission: K013536
- Applicant / Sponsor: Gynetics Medical Products NV
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6110
- Decision date: 2001-11-30
Classification & Regulation
This clearance is catalogued under FDA product code MQF and 21 CFR 884.6110, within the Obstetrics/Gynecology review panel as a Class II device.