Clearance Summary
SIM 4000I received FDA 510(k) clearance under submission number K873845, sponsored by Ote-Biomedica Elettronica S.P.A. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1988-04-07.
- Submission: K873845
- Applicant / Sponsor: Ote-Biomedica Elettronica S.P.A
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 1988-04-07
Classification & Regulation
This clearance is catalogued under FDA product code IYO and 21 CFR 892.1560, within the Radiology review panel as a Class II device.