Cleared Traditional

IM007

K210543 · Implicity, Inc. · Cardiovascular
Nov 2021
Decision
252d
Days
Class 2
Risk

About This 510(k) Submission

K210543 is an FDA 510(k) clearance for the IM007, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Implicity, Inc. (Cambridge, US). The FDA issued a Cleared decision on November 3, 2021, 252 days after receiving the submission on February 24, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K210543 FDA.gov
FDA Decision Cleared SESE
Date Received February 24, 2021
Decision Date November 03, 2021
Days to Decision 252 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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