Clearance Summary
TOITU DOPPLER FETUS DETECTOR, FD-400D received FDA 510(k) clearance under submission number K890139, sponsored by Toitu of America, 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 1989-03-29.
- Submission: K890139
- Applicant / Sponsor: Toitu of America, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2660
- Decision date: 1989-03-29
Classification & Regulation
This clearance is catalogued under FDA product code KNG and 21 CFR 884.2660, within the Obstetrics/Gynecology review panel as a Class II device.