Cleared Traditional

QT ECG

K180157 · QT Medical, Inc. · Cardiovascular
May 2018
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K180157 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. (Torrance, US). The FDA issued a Cleared decision on May 4, 2018, 105 days after receiving the submission on January 19, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2920.

Submission Details

510(k) Number K180157 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 2018
Decision Date May 04, 2018
Days to Decision 105 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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