Cleared Traditional

Q Patch

K210758 · Medicalgorithmics S.A. · Cardiovascular
Jun 2022
Decision
444d
Days
Class 2
Risk

About This 510(k) Submission

K210758 is an FDA 510(k) clearance for the Q Patch, a Electrocardiograph, Ambulatory (without Analysis) (Class II — Special Controls, product code MWJ), submitted by Medicalgorithmics S.A. (Warsaw, PL). The FDA issued a Cleared decision on June 2, 2022, 444 days after receiving the submission on March 15, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number K210758 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 2021
Decision Date June 02, 2022
Days to Decision 444 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