BLEASE 6200 ANAESTHESIA VENTILATOR

K982132 · Blease Medical Equipment , Ltd. · CBK · Apr 15, 1999 · Anesthesiology

Device Facts

• Record ID: K982132
• Device Name: BLEASE 6200 ANAESTHESIA VENTILATOR
• Applicant: Blease Medical Equipment , Ltd.
• Product Code: CBK · Anesthesiology
• Decision Date: Apr 15, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Blease 6200 anaesthesia ventilator is an advanced microprocessor controlled, pneumatically powered ventilator for 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; 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 Story

Blease 6200 is a microprocessor-controlled, pneumatically powered anesthesia ventilator. It provides mechanical ventilation for adult and pediatric patients undergoing general anesthesia. The device integrates with circle-type absorbers or Jackson-Rees/Ayres T-piece circuits for both low-flow and high-flow applications. Operated by qualified physicians in clinical settings, the ventilator manages respiratory support during surgical procedures. It functions as a controller to regulate gas delivery and ventilation parameters, assisting in patient maintenance under anesthesia.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Microprocessor-controlled, pneumatically powered anesthesia ventilator. Designed for integration with circle-type absorbers and Jackson-Rees/Ayres T-piece circuits. Supports low-flow and high-flow applications.

Indications for Use

Indicated for adult and pediatric patients requiring mechanical ventilation during general anesthesia. Used with circle type absorbers or Jackson-Rees/Ayres T-piece circuits.

Regulatory Classification

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.

Submission Summary (Full Text)

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Public Health Service

APR 15 :33

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Richard H. Cooke Blease Medical Equipment Limited c/o Mr. Francis X. Casey Invivo Research, Inc. 12601 Research Parkway Orlando, FL 32826

Re : K982132 Blease 6200 Anesthesia Ventilator II (two) Regulatory Class: Product Code: 73 CBK February 2, 1999 Dated: February 5, 1999 Received:

Dear Mr. Cooke:

We have reviewed your Section 510(k) notification of intent to market we have review food above and we have determined the device is the device referenced above and indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Interstate commerce problem of to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls ine general concrols provisions quirements for annual registration, pisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special II your dovied in (Premarket Approval), it may be subject to such Controls) of Class III (Freakines offecting your device add cronar concessor Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. es 650. In Burrent Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this concerning your device notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Richard H. Cooke

This letter will allow you to begin marketing your device as described This letter will afrow you co begin marksberg of substantial in your 310(K) premairket notification marketed predicate device equivalence of your device to a regarly manitor.
results in a classification for your device and thus, permits your device to proceed to the market.

If you dosire specific advice for your device on our labeling If you desire specific advice for your additionally 809.10 for in vitro regulation (2) crk rate are contact the Office of Compliance at diagnostic devices) predoc v. for questions on the promotion and [phone]. Addressary, 101 gassect the Office of Compliance at [phone]. Also, please note the regulation entitled, (301) 39-4053. "Also, premarket notification"(21 CFR 807.97). Misoranding by Leronon on your responsibilities under the Act may other general information of your manufacturers Assistance at its be obcailled from the Britison of 301) 443-6597, or at its internet corr rree number (000) { vse, corn/dsma/dsmamain.html".

Sincerely yours,
Thomas J. Callehan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INTENDED USE STATEMENT

The Blease 6200 anaesthesia ventilator is an advanced microprocessor The Blease uzoo andoothoola Tonnilator (controller) specifically designed for controlled, pheumatiouny ewolf and paediatric patients under general anaesthesia.

It is designed for use with a circle type absorber and is ideally suited to both it is designed for assume the ventilator may also be used with low-now and high now applications 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.

A.L.A. Grahame.

insion Sinn-Off Division of Cardiovascular, Respiratory, and Neurological Dey 510(k) Number

pecumptions use
801.109

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