Clearance Summary
CALYSTO SERIES IV PHYSIO-MONITORING AND INFORMATION SYSTEM received FDA 510(k) clearance under submission number K063547, sponsored by Witt Biomedical Corp. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2006-12-21.
- Submission: K063547
- Applicant / Sponsor: Witt Biomedical Corp
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 2006-12-21
Classification & Regulation
This clearance is catalogued under FDA product code MWI and 21 CFR 870.2300, within the Cardiovascular review panel as a Class II device.