Cleared Traditional

AT-Patch ECG Analysis System

K203638 · Atsens Co., Ltd. · Cardiovascular
Oct 2022
Decision
667d
Days
Class 2
Risk

About This 510(k) Submission

K203638 is an FDA 510(k) clearance for the AT-Patch ECG Analysis System, a Recorder, Magnetic Tape, Medical (Class II — Special Controls, product code DSH), submitted by Atsens Co., Ltd. (Seongnam-Si, KR). The FDA issued a Cleared decision on October 12, 2022, 667 days after receiving the submission on December 14, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number K203638 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 2020
Decision Date October 12, 2022
Days to Decision 667 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DSH — Recorder, Magnetic Tape, Medical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2800