Cleared Traditional

Cardio10

K220535 · Bionet Co., Ltd. · Cardiovascular
Nov 2022
Decision
264d
Days
Class 2
Risk

About This 510(k) Submission

K220535 is an FDA 510(k) clearance for the Cardio10, a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by Bionet Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on November 15, 2022, 264 days after receiving the submission on February 24, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K220535 FDA.gov
FDA Decision Cleared SESE
Date Received February 24, 2022
Decision Date November 15, 2022
Days to Decision 264 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DPS — Electrocardiograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2340