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K Number
K011861
Device Name
BERNOULLI VENTILATOR MANAGEMENT SYSTEM
Manufacturer
CARDIOPULMONARY CORP.
Date Cleared
2001-11-06

(145 days)

Product Code
MOD
Regulation Number
868.5895
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Bernoulli VMS software is intended to be used on a central monitoring station on mechanically ventilated patients in a hospital or hospital type environment. It is used to provide a secondary display of the ventilator data to the central station, and to provide remote monitoring and alarm surveillance. The Bernoulli VMS is intended to supplement and not replace any part of the current device monitoring procedures.

Device Description

Bernoulli™ Ventilator Management System

AI/ML Overview

The provided text describes a 510(k) clearance for the Bernoulli™ Ventilator Management System but does not contain information about the acceptance criteria, reported device performance, or details of a study demonstrating such performance. It is a regulatory clearance letter and an "Indications for Use Statement".

Therefore, I cannot provide the requested information.

§ 868.5895 Continuous ventilator.

(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).