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— 510(k) K151040

Substantially Equivalent

Biometrix , Ltd.

FDA 510(k) clearance K151040 for 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, Substantially Equivalent on 2015-09-04. Applicant: Biometrix , Ltd..

Clearance details

Applicant: Biometrix , Ltd.
Product code: Code DRS
Advisory panel: Cardiovascular
Date received: 2015-04-20
Decision date: 2015-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jerusalem, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRS

product code DRS

Death: 8
Malfunction: 776
Total: 784

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.