Cleared Special

Biotres

K222017 · Biotricity · Cardiovascular
Jul 2022
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K222017 is an FDA 510(k) clearance for the Biotres, a Electrocardiograph, Ambulatory (without Analysis) (Class II — Special Controls, product code MWJ), submitted by Biotricity (Redwood City, US). The FDA issued a Cleared decision on July 28, 2022, 20 days after receiving the submission on July 8, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number K222017 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 2022
Decision Date July 28, 2022
Days to Decision 20 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MWJ — Electrocardiograph, Ambulatory (without Analysis)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2800