Clearance Summary
1000 PRESSURE INFUSION SIGMACON 1000 received FDA 510(k) clearance under submission number K990447, sponsored by Valley West, 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 1999-05-12.
- Submission: K990447
- Applicant / Sponsor: Valley West, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 1999-05-12
Classification & Regulation
This clearance is catalogued under FDA product code FRN and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.