NOWCARDIO SYSTEM— 510(k) K162956

Substantially Equivalent

Contex International Technologies (Canada), Inc.

FDA 510(k) clearance K162956 for NOWCARDIO SYSTEM, Substantially Equivalent on 2017-09-22. Applicant: Contex International Technologies (Canada), Inc..

Clearance details

Applicant: Contex International Technologies (Canada), Inc.
Product code: Code QYX
Advisory panel: Cardiovascular
Date received: 2016-10-24
Decision date: 2017-09-22
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Mississauga, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code QYX

product code QYX

Death: 13
Malfunction: 526
Total: 539

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.