Clearance Summary
INFRARED EXPOSURE HAND SWITCH received FDA 510(k) clearance under submission number K950442, sponsored by Medical X-Ray Intl., 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 1995-03-31.
- Submission: K950442
- Applicant / Sponsor: Medical X-Ray Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1980
- Decision date: 1995-03-31
Classification & Regulation
This clearance is catalogued under FDA product code KXJ and 21 CFR 892.1980, within the Radiology review panel as a Class II device.