Cleared Special

WorkMate Claris System

K210392 · Abbott · Cardiovascular
Mar 2021
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K210392 is an FDA 510(k) clearance for the WorkMate Claris System, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Abbott (St. Paul, US). The FDA issued a Cleared decision on March 11, 2021, 29 days after receiving the submission on February 10, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K210392 FDA.gov
FDA Decision Cleared SESE
Date Received February 10, 2021
Decision Date March 11, 2021
Days to Decision 29 days
Submission Type Special
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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