Clearance Summary
PROWESS PRO-SIM received FDA 510(k) clearance under submission number K980379, sponsored by Ssgi Prowess Systems. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1998-05-18.
- Submission: K980379
- Applicant / Sponsor: Ssgi Prowess Systems
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 1998-05-18
Classification & Regulation
This clearance is catalogued under FDA product code IYE and 21 CFR 892.5050, within the Radiology review panel as a Class II device.