QUINTON Q-TE; RMS— 510(k) K041607

Name: FDA 510(k) clearance K041607
Creator: U.S. Food and Drug Administration
Published: 2004-07-16

Substantially Equivalent

Quinton Cardiology, Inc.

FDA 510(k) clearance K041607 for QUINTON Q-TE; RMS, Substantially Equivalent on 2004-07-16. Applicant: Quinton Cardiology, Inc.. Device class: 2.

Clearance details

Applicant: Quinton Cardiology, Inc.
Product code: Code MHX
Device class: Class 2
Regulation: 21 CFR 870.1025
Advisory panel: Cardiovascular
Date received: 2004-06-15
Decision date: 2004-07-16
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Bothell, WA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MHX

product code MHX

Death: 580
Injury: 2,441
Malfunction: 12,655
Other: 3
Total: 15,679

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 →

Recalls naming K041607

K-number listed on FDA's recall record

Z-1818-2020 — Q-Tel. The Q-Tel RMS system is a computer-based cardiac and pulmonary rehabilitation data acquisition and editing system.Class II·Terminated·WELCH ALLYN, INC/MORTARA·20200318

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K041607.

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