Clearance Summary
EXACON THERMOMETER SYSTEM 8000 received FDA 510(k) clearance under submission number K821555, sponsored by Sat Export Engineering & Trading. 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 1982-08-16.
- Submission: K821555
- Applicant / Sponsor: Sat Export Engineering & Trading
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 1982-08-16
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.