Cleared Traditional

Ablamap Software

K203084 · Ablacon, Inc. · Cardiovascular
Aug 2021
Decision
322d
Days
Class 2
Risk

About This 510(k) Submission

K203084 is an FDA 510(k) clearance for the Ablamap Software, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Ablacon, Inc. (Denver, US). The FDA issued a Cleared decision on August 31, 2021, 322 days after receiving the submission on October 13, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K203084 FDA.gov
FDA Decision Cleared SESE
Date Received October 13, 2020
Decision Date August 31, 2021
Days to Decision 322 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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