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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K982174
Device Name VENTURI VENTILATOR
Applicant
Cardiopulmonary Corp.
200 Cascade Blvd.
Milford,  CT  06460
Applicant Contact JAMES W BIONDI
Correspondent
Cardiopulmonary Corp.
200 Cascade Blvd.
Milford,  CT  06460
Correspondent Contact JAMES W BIONDI
Regulation Number868.5895
Classification Product Code
CBK  
Date Received06/17/1998
Decision Date 06/24/1998
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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