Clearance Summary
MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENA received FDA 510(k) clearance under submission number K915633, sponsored by S & W Medico Teknik. 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 1993-06-29.
- Submission: K915633
- Applicant / Sponsor: S & W Medico Teknik
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 1993-06-29
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.