Cleared Traditional

MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE

K020018 · Cardiopulmonary Corp. · Cardiovascular
Feb 2002
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K020018 is an FDA 510(k) clearance for the MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM 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 February 21, 2002, 49 days after receiving the submission on January 3, 2002. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number K020018 FDA.gov
FDA Decision Cleared SESE
Date Received January 03, 2002
Decision Date February 21, 2002
Days to Decision 49 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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