Cleared Traditional

QT ECG

K220795 · QT Medical, Inc. · Cardiovascular
Sep 2022
Decision
192d
Days
Class 2
Risk

About This 510(k) Submission

K220795 is an FDA 510(k) clearance for the QT ECG, 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 September 26, 2022, 192 days after receiving the submission on March 18, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2920.

Submission Details

510(k) Number K220795 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 2022
Decision Date September 26, 2022
Days to Decision 192 days
Submission Type Traditional
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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