Cleared Traditional

NeuTrace EP Mapping System v.2.1

K233160 · Anumana, Inc. · Cardiovascular
Nov 2023
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K233160 is an FDA 510(k) clearance for the NeuTrace EP Mapping System v.2.1, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Anumana, Inc. (Cambridge, US). The FDA issued a Cleared decision on November 25, 2023, 59 days after receiving the submission on September 27, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K233160 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2023
Decision Date November 25, 2023
Days to Decision 59 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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