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K Number
K982132
Device Name
BLEASE 6200 ANAESTHESIA VENTILATOR
Manufacturer
BLEASE MEDICAL EQUIPMENT LTD.
Date Cleared
1999-04-15

(302 days)

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

The Blease 6200 anaesthesia ventilator is an advanced microprocessor (controller) specifically designed for controlled, pneumatically powered ventilation of adult and paediatric patients under general anaesthesia. It is designed for use with a circle type absorber and is ideally suited to both low-flow and high flow applications. It is assumed the ventilator may also be used with a Jackson-Rees/Ayres T-piece type paediatric circuit with no modification being necessary. The device is intended for use only by a suitably qualified physician.

Device Description

The Blease 6200 anaesthesia ventilator is an advanced microprocessor (controller) specifically designed for controlled, pneumatically powered ventilation of adult and paediatric patients under general anaesthesia.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Blease 6200 Anesthesia Ventilator II. However, it does not contain any information regarding:

  • Acceptance criteria and reported device performance.
  • The specifics of any study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods).
  • Whether MRMC or standalone studies were conducted.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

The document is a letter from the FDA confirming the 510(k) clearance for the device and an "Intended Use Statement" for the Blease 6200 Anesthesia Ventilator. It does not delve into the technical details of the device's performance or the studies that led to its clearance beyond confirming its substantial equivalence to legally marketed predicate devices.

§ 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).