Cleared Traditional

Biotres

K211709 · Biotricity · Cardiovascular
Jan 2022
Decision
230d
Days
Class 2
Risk

About This 510(k) Submission

K211709 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 January 19, 2022, 230 days after receiving the submission on June 3, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number K211709 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 2021
Decision Date January 19, 2022
Days to Decision 230 days
Submission Type Traditional
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