Clearance Summary
TASK FORCE MONITOR 3040 received FDA 510(k) clearance under submission number K014063, sponsored by Cnsystems Medizintechnik GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2002-02-07.
- Submission: K014063
- Applicant / Sponsor: Cnsystems Medizintechnik GmbH
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2770
- Decision date: 2002-02-07
Classification & Regulation
This clearance is catalogued under FDA product code DSB and 21 CFR 870.2770, within the Cardiovascular review panel as a Class II device.