Clearance Summary
VIEW-LITE, MODEL-DL received FDA 510(k) clearance under submission number K802216, sponsored by Med-Western Electronics, 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 1980-10-23.
- Submission: K802216
- Applicant / Sponsor: Med-Western Electronics, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1890
- Decision date: 1980-10-23
Classification & Regulation
This clearance is catalogued under FDA product code IXC and 21 CFR 892.1890, within the Radiology review panel as a Class I device.