Clearance Summary
GENIUS 2 INFRARED TYMPANIC ELECTRONIC THERMOMETER, MODEL 303000 received FDA 510(k) clearance under submission number K060649, sponsored by Tyco Healthcare Group LP. 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 2006-05-22.
- Submission: K060649
- Applicant / Sponsor: Tyco Healthcare Group LP
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2006-05-22
Classification & Regulation
This clearance is catalogued under FDA product code FLL and 21 CFR 880.2910, within the General Hospital review panel as a Class II device.