Clearance Summary
1MHZ CW DOPPLER TRANSDUCER W/LILY ANTEPARTUM #507 received FDA 510(k) clearance under submission number K860621, sponsored by Impex 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 1986-05-20.
- Submission: K860621
- Applicant / Sponsor: Impex Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2960
- Decision date: 1986-05-20
Classification & Regulation
This clearance is catalogued under FDA product code HGL and 21 CFR 884.2960, within the Obstetrics/Gynecology review panel as a Class II device.