Clearance Summary
ER-1000 CATHERIZATION C-ARM SYSTEMS received FDA 510(k) clearance under submission number K914348, sponsored by Shimadzu Medical 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 1991-11-01.
- Submission: K914348
- Applicant / Sponsor: Shimadzu Medical Systems
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1770
- Decision date: 1991-11-01
Classification & Regulation
This clearance is catalogued under FDA product code IYB and 21 CFR 892.1770, within the Radiology review panel as a Class I device.