Cleared Special

MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE

K051283 · Cardiopulmonary Corp. · Cardiovascular
Jun 2005
Decision
37d
Days
Class 2
Risk

About This 510(k) Submission

K051283 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 June 23, 2005, 37 days after receiving the submission on May 17, 2005. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number K051283 FDA.gov
FDA Decision Cleared SESE
Date Received May 17, 2005
Decision Date June 23, 2005
Days to Decision 37 days
Submission Type Special
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

Similar Devices — MSX System, Network And Communication, Physiological Monitors

All 115
TigerConnect Alarm Management
K243270 · Tigerconnect · Sep 2025
BeneVision Central Monitoring System
K242728 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jul 2025
Central Station
K242750 · Nihon Kohden Digital Health Solutions, LLC · Jun 2025
ANNE View, Central Hub
K242842 · Sibel Health, Inc. · Jan 2025
Hinscope
K241397 · Hinlab Sas · Nov 2024
Infinity Gateway Suite
K233834 · Draeger Medical Systems, Inc. · Jul 2024