Clearance Summary
RADIOGRAPHIC WALL-MOUNTED CASSETTE HOLDER received FDA 510(k) clearance under submission number K930230, sponsored by American Medical Sales, 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 1993-04-27.
- Submission: K930230
- Applicant / Sponsor: American Medical Sales, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1880
- Decision date: 1993-04-27
Classification & Regulation
This clearance is catalogued under FDA product code IXY and 21 CFR 892.1880, within the Radiology review panel as a Class I device.