Cleared Special

V2.7 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM

K141185 · Boston Scientific Corp · Cardiovascular
Jun 2014
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K141185 is an FDA 510(k) clearance for the V2.7 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Boston Scientific Corp (Lowell, US). The FDA issued a Cleared decision on June 6, 2014, 30 days after receiving the submission on May 7, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K141185 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 2014
Decision Date June 06, 2014
Days to Decision 30 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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