Clearance Summary
ELECTRONIC X-RAY TIMER 1400A, 1400AW AND UNIVERSAL DIGITAL DENTAL X-RAY TIMER received FDA 510(k) clearance under submission number K963185, sponsored by Electronic Control Concepts. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1996-10-02.
- Submission: K963185
- Applicant / Sponsor: Electronic Control Concepts
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1800
- Decision date: 1996-10-02
Classification & Regulation
This clearance is catalogued under FDA product code EHD and 21 CFR 872.1800, within the Dental review panel as a Class II device.