Clearance Summary
FETAL PULSE DETECTOR MODEL DOP-1 received FDA 510(k) clearance under submission number K902190, sponsored by Advanced Medical Systems, 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 1990-10-22.
- Submission: K902190
- Applicant / Sponsor: Advanced Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2660
- Decision date: 1990-10-22
Classification & Regulation
This clearance is catalogued under FDA product code HEK and 21 CFR 884.2660, within the Obstetrics/Gynecology review panel as a Class II device.