Clearance Summary
COLOR DOPPLER OPTION TO AI 5200 DIAG ULTRASO SYST received FDA 510(k) clearance under submission number K910212, sponsored by Acoustic Imaging Technologies Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 1991-07-11.
- Submission: K910212
- Applicant / Sponsor: Acoustic Imaging Technologies Corp.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4420
- Decision date: 1991-07-11
Classification & Regulation
This clearance is catalogued under FDA product code JYO and 21 CFR 874.4420, within the Ear, Nose, Throat review panel as a Class I device.