Cleared Traditional

BERNOULLI MANAGEMENT SYSTEM (MS) SOFTWARE

K061932 · Cardiopulmonary Corp. · Cardiovascular
Sep 2006
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K061932 is an FDA 510(k) clearance for the BERNOULLI MANAGEMENT SYSTEM (MS) SOFTWARE, a System, Network And Communication, Physiological Monitors (Class II — Special Controls, product code MSX), submitted by Cardiopulmonary Corp. (Milford, US). The FDA issued a Cleared decision on September 14, 2006, 69 days after receiving the submission on July 7, 2006. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number K061932 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 2006
Decision Date September 14, 2006
Days to Decision 69 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code MSX — System, Network And Communication, Physiological Monitors
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2300

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