Clearance Summary
FETAL DOPPLER FOR ULTRAMARK 4 AND 8 received FDA 510(k) clearance under submission number K881329, sponsored by Advanced Technology Laboratories, 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 1989-04-14.
- Submission: K881329
- Applicant / Sponsor: Advanced Technology Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2225
- Decision date: 1989-04-14
Classification & Regulation
This clearance is catalogued under FDA product code HEM and 21 CFR 884.2225, within the Obstetrics/Gynecology review panel as a Class II device.