Clearance Summary
14 COLOR VIDEO DISPLAY 211-260-010 received FDA 510(k) clearance under submission number K893585, sponsored by Mennen Medical, 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 1989-07-20.
- Submission: K893585
- Applicant / Sponsor: Mennen Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 1989-07-20
Classification & Regulation
This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.