Clearance Summary
OMRON MODEL 514N TYMPANIC THERMOMETER received FDA 510(k) clearance under submission number K051233, sponsored by Omron Healthcare, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2005-06-21.
- Submission: K051233
- Applicant / Sponsor: Omron Healthcare, Inc.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2005-06-21
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.