Cleared Special

QT ECG (QTERD100)

K233521 · QT Medical, Inc. · Cardiovascular
Dec 2023
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K233521 is an FDA 510(k) clearance for the QT ECG (QTERD100), a Transmitters And Receivers, Electrocardiograph, Telephone (Class II — Special Controls, product code DXH), submitted by QT Medical, Inc. (Diamond Bar, US). The FDA issued a Cleared decision on December 6, 2023, 35 days after receiving the submission on November 1, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2920.

Submission Details

510(k) Number K233521 FDA.gov
FDA Decision Cleared SESE
Date Received November 01, 2023
Decision Date December 06, 2023
Days to Decision 35 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXH — Transmitters And Receivers, Electrocardiograph, Telephone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2920

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