Cleared Traditional

BERNOULLI ENTERPRISE SOFTWARE

K130208 · Cardiopulmonary Corp. · Cardiovascular
Dec 2013
Decision
326d
Days
Class 2
Risk

About This 510(k) Submission

K130208 is an FDA 510(k) clearance for the BERNOULLI ENTERPRISE SOFTWARE, a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX), submitted by Cardiopulmonary Corp. (Milford, US). The FDA issued a Cleared decision on December 20, 2013, 326 days after receiving the submission on January 28, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K130208 FDA.gov
FDA Decision Cleared SESE
Date Received January 28, 2013
Decision Date December 20, 2013
Days to Decision 326 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code MHX — Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1025

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