Clearance Summary
RMI ULTRASOUND DOPPLER PHANTOM SYSTEM received FDA 510(k) clearance under submission number K893216, sponsored by Radiation Measurements, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1989-09-05.
- Submission: K893216
- Applicant / Sponsor: Radiation Measurements, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class I
- Regulation citation: 21 CFR 882.1925
- Decision date: 1989-09-05
Classification & Regulation
This clearance is catalogued under FDA product code GXX and 21 CFR 882.1925, within the Neurology review panel as a Class I device.