Clearance Summary
DECOMAT 228 received FDA 510(k) clearance under submission number K920406, sponsored by Getinge International, 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 1994-04-05.
- Submission: K920406
- Applicant / Sponsor: Getinge International, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6992
- Decision date: 1994-04-05
Classification & Regulation
This clearance is catalogued under FDA product code MDZ and 21 CFR 880.6992, within the General Hospital review panel as a Class II device.