Clearance Summary
TERPERATUR SENSING DEVICE received FDA 510(k) clearance under submission number K802607, sponsored by Burditt & Calkins-Siemens-Elema. 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 1980-11-19.
- Submission: K802607
- Applicant / Sponsor: Burditt & Calkins-Siemens-Elema
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 1980-11-19
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.