Clearance Summary
DECOMAT 4656 received FDA 510(k) clearance under submission number K950566, sponsored by Getinge Disinfection, Inc.. 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 1995-10-19.
- Submission: K950566
- Applicant / Sponsor: Getinge Disinfection, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6991
- Decision date: 1995-10-19
Classification & Regulation
This clearance is catalogued under FDA product code LDS and 21 CFR 880.6991, within the General Hospital review panel as a Class II device.