Clearance Summary
CRIT-LINE MONITOR III (CLM III) received FDA 510(k) clearance under submission number K001763, sponsored by In-Line Diagnostics Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2000-12-20.
- Submission: K001763
- Applicant / Sponsor: In-Line Diagnostics Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 2000-12-20
Classification & Regulation
This clearance is catalogued under FDA product code MQS and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.