Clearance Summary
EHS SERIES TABLE TOP AUTOCLAVE, MODELS 2540 AND 3870 received FDA 510(k) clearance under submission number K003470, sponsored by Tuttnauer Co. , Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2001-02-20.
- Submission: K003470
- Applicant / Sponsor: Tuttnauer Co. , Ltd.
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6880
- Decision date: 2001-02-20
Classification & Regulation
This clearance is catalogued under FDA product code FLE and 21 CFR 880.6880, within the General Hospital review panel as a Class II device.