NOWCARDIO SYSTEM— 510(k) K162956

Name: FDA 510(k) clearance K162956
Creator: U.S. Food and Drug Administration
Published: 2017-09-22

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.. Device class: 2.

Clearance details

Applicant: Contex International Technologies (Canada), Inc.
Product code: Code QYX
Device class: Class 2
Regulation: 21 CFR 870.1025
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 ↗

Recent devices under product code QYX

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K250793 — RhythmStar System (SL)2026-04-21
K241179 — Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)2025-07-11
K240653 — SmartCardia 7L Platform (MCT)2024-10-31
K240029 — Zio AT® device (A100A1001)2024-10-21
K233584 — RhythmStar System2024-07-08

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.