Clearance Summary
CT-1000A SYSTEM received FDA 510(k) clearance under submission number K896779, sponsored by Bio-Monitor, 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 1990-06-01.
- Submission: K896779
- Applicant / Sponsor: Bio-Monitor, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 1990-06-01
Classification & Regulation
This clearance is catalogued under FDA product code FLL and 21 CFR 880.2910, within the General Hospital review panel as a Class II device.