Clearance Summary
Unite Connect for Clinical Systems received FDA 510(k) clearance under submission number K180566, sponsored by Ascom Sweden AB. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2018-04-03.
- Submission: K180566
- Applicant / Sponsor: Ascom Sweden AB
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 2018-04-03
Classification & Regulation
This clearance is catalogued under FDA product code MSX and 21 CFR 870.2300, within the Cardiovascular review panel as a Class II device.