Clearance Summary
TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE received FDA 510(k) clearance under submission number K965154, sponsored by Albert Browne , 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 1997-09-19.
- Submission: K965154
- Applicant / Sponsor: Albert Browne , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2800
- Decision date: 1997-09-19
Classification & Regulation
This clearance is catalogued under FDA product code LRT and 21 CFR 880.2800, within the General Hospital review panel as a Class II device.