Cleared Traditional

RhythmAnalytics

K182344 · Biofourmis Singapore Pte., Ltd. · Cardiovascular
Mar 2019
Decision
191d
Days
Class 2
Risk

About This 510(k) Submission

K182344 is an FDA 510(k) clearance for the RhythmAnalytics, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Biofourmis Singapore Pte., Ltd. (Singapore, SG). The FDA issued a Cleared decision on March 7, 2019, 191 days after receiving the submission on August 28, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K182344 FDA.gov
FDA Decision Cleared SESE
Date Received August 28, 2018
Decision Date March 07, 2019
Days to Decision 191 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQK — Computer, Diagnostic, Programmable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1425

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