Clearance Summary
Art-line Single channel blood pressure system, Art-line Double channel blood pressure system, Art-line Triple channel blood pressure system, IAP Monitoring Set with Disposable Transducer received FDA 510(k) clearance under submission number K151040, sponsored by Biometrix , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2015-09-04.
- Submission: K151040
- Applicant / Sponsor: Biometrix , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2850
- Decision date: 2015-09-04
Classification & Regulation
This clearance is catalogued under FDA product code DRS and 21 CFR 870.2850, within the Cardiovascular review panel as a Class II device.