Clearance Summary
THERMOMETER, DIGITAL FEVER (MEDITEMP) received FDA 510(k) clearance under submission number K760118, sponsored by Johnson & Johnson Professionals, Inc.. 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 1976-07-20.
- Submission: K760118
- Applicant / Sponsor: Johnson & Johnson Professionals, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 1976-07-20
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.