Clearance Summary
TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING received FDA 510(k) clearance under submission number K010920, sponsored by Medical Cables, Inc.. 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 2001-06-22.
- Submission: K010920
- Applicant / Sponsor: Medical Cables, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2660
- Decision date: 2001-06-22
Classification & Regulation
This clearance is catalogued under FDA product code HEL and 21 CFR 884.2660, within the Obstetrics/Gynecology review panel as a Class II device.