Clearance Summary
C/T MED-SYSTEMS CASSETTE SYSTEM received FDA 510(k) clearance under submission number K980065, sponsored by C/T Med System, Ltd.. 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 1998-05-11.
- Submission: K980065
- Applicant / Sponsor: C/T Med System, Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6850
- Decision date: 1998-05-11
Classification & Regulation
This clearance is catalogued under FDA product code KCT and 21 CFR 880.6850, within the General Hospital review panel as a Class II device.