Cleared Traditional

ZBPro Diagnostic

K243252 · Zbeats, Inc. · Cardiovascular
Jul 2025
Decision
268d
Days
Class 2
Risk

About This 510(k) Submission

K243252 is an FDA 510(k) clearance for the ZBPro Diagnostic, a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by Zbeats, Inc. (Stony Brook, US). The FDA issued a Cleared decision on July 10, 2025, 268 days after receiving the submission on October 15, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K243252 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 2024
Decision Date July 10, 2025
Days to Decision 268 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