NUVANT, MOBILE CARDIAC TELEMETRY— 510(k) K111917

Name: FDA 510(k) clearance K111917
Creator: U.S. Food and Drug Administration
Published: 2011-08-24

Substantially Equivalent

Corventis, Inc.

FDA 510(k) clearance K111917 for NUVANT, MOBILE CARDIAC TELEMETRY, Substantially Equivalent on 2011-08-24. Applicant: Corventis, Inc.. Device class: 2.

Clearance details

Applicant: Corventis, Inc.
Product code: Code QYX
Device class: Class 2
Regulation: 21 CFR 870.1025
Advisory panel: Cardiovascular
Date received: 2011-07-06
Decision date: 2011-08-24
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

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K091971 — AVIVO MOBILE PATIENT MANAGEMENT SYSTEM, NUVANT MOBILE CARDIAC TELEMETRY (MCT) SYSTEM2009-08-27
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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.