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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 K943412
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 Received07/14/1994
Decision Date 10/16/1995
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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