Clearance Summary
OX-600 received FDA 510(k) clearance under submission number K920196, sponsored by Stardard X-Ray Sales Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1992-10-14.
- Submission: K920196
- Applicant / Sponsor: Stardard X-Ray Sales Co.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1860
- Decision date: 1992-10-14
Classification & Regulation
This clearance is catalogued under FDA product code KPX and 21 CFR 892.1860, within the Radiology review panel as a Class II device.