Clearance Summary
CLINITRON C-10 received FDA 510(k) clearance under submission number K914351, sponsored by Ssi Medical Services, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1992-02-14.
- Submission: K914351
- Applicant / Sponsor: Ssi Medical Services, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1980
- Decision date: 1992-02-14
Classification & Regulation
This clearance is catalogued under FDA product code IXQ and 21 CFR 892.1980, within the Radiology review panel as a Class II device.