Cleared Traditional

Cardio P1

K231150 · Bionet Co., Ltd. · Cardiovascular
Nov 2023
Decision
202d
Days
Class 2
Risk

About This 510(k) Submission

K231150 is an FDA 510(k) clearance for the Cardio P1, a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by Bionet Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on November 9, 2023, 202 days after receiving the submission on April 21, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K231150 FDA.gov
FDA Decision Cleared SESE
Date Received April 21, 2023
Decision Date November 09, 2023
Days to Decision 202 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