Clearance Summary
7400 Ultrasound Systems received FDA 510(k) clearance under submission number K190447, sponsored by Navigant Consulting - on Behalf of Esaote S.P.A.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2019-04-01.
- Submission: K190447
- Applicant / Sponsor: Navigant Consulting - on Behalf of Esaote S.P.A.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 2019-04-01
Classification & Regulation
This clearance is catalogued under FDA product code IYN and 21 CFR 892.1550, within the Radiology review panel as a Class II device.