Clearance Summary
NOWCARDIO SYSTEM received FDA 510(k) clearance under submission number K162956, sponsored by Contex International Technologies (Canada), Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2017-09-22.
- Submission: K162956
- Applicant / Sponsor: Contex International Technologies (Canada), Inc.
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 2017-09-22
Classification & Regulation
This clearance is catalogued under FDA product code QYX and 21 CFR 870.1025, within the Cardiovascular review panel as a Class II device.