Clearance Summary
IVID received FDA 510(k) clearance under submission number K950200, sponsored by Scott/Ross Designs, 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 1995-03-24.
- Submission: K950200
- Applicant / Sponsor: Scott/Ross Designs, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 1995-03-24
Classification & Regulation
This clearance is catalogued under FDA product code FPK and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.