Clearance Summary
CAPTUS 2000 WEL COUNTER received FDA 510(k) clearance under submission number K930962, sponsored by Capintec Instruments, 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 1993-05-18.
- Submission: K930962
- Applicant / Sponsor: Capintec Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1320
- Decision date: 1993-05-18
Classification & Regulation
This clearance is catalogued under FDA product code IZD and 21 CFR 892.1320, within the Radiology review panel as a Class I device.