Clearance Summary
MEDDEV MULTARRAY MEDICAL EXAMINING LIGHT MODIFICATION received FDA 510(k) clearance under submission number K940284, sponsored by Meddev International Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1994-02-28.
- Submission: K940284
- Applicant / Sponsor: Meddev International Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6320
- Decision date: 1994-02-28
Classification & Regulation
This clearance is catalogued under FDA product code KZF and 21 CFR 880.6320, within the General Hospital review panel as a Class I device.