Clearance Summary
OVULATION CALCULATOR/CONCEPTION CALCULATOR received FDA 510(k) clearance under submission number K954183, sponsored by Hector Vides. 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 1996-02-29.
- Submission: K954183
- Applicant / Sponsor: Hector Vides
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5350
- Decision date: 1996-02-29
Classification & Regulation
This clearance is catalogued under FDA product code MPT and 21 CFR 884.5350, within the Obstetrics/Gynecology review panel as a Class II device.