Clearance Summary
REFLEX(R) ESC received FDA 510(k) clearance under submission number K924200, sponsored by Richard-Allan Medical Ind., 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 1994-02-22.
- Submission: K924200
- Applicant / Sponsor: Richard-Allan Medical Ind., Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4160
- Decision date: 1994-02-22
Classification & Regulation
This clearance is catalogued under FDA product code KNF and 21 CFR 884.4160, within the Obstetrics/Gynecology review panel as a Class II device.