Clearance Summary
PATIENT TEMPERATURE MONITOR, MODEL 1000 received FDA 510(k) clearance under submission number K874159, sponsored by Sonodyne America, Ltd.. 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 1987-11-23.
- Submission: K874159
- Applicant / Sponsor: Sonodyne America, Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 1987-11-23
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.