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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory To Continuous Ventilator (Respirator)
510(k) Number K011861
Device Name BERNOULLI VENTILATOR MANAGEMENT SYSTEM
Applicant
Cardiopulmonary Corp.
200 Cascade Blvd.
Milford,  CT  06460
Applicant Contact JOHN LAVIOLA
Correspondent
Cardiopulmonary Corp.
200 Cascade Blvd.
Milford,  CT  06460
Correspondent Contact JOHN LAVIOLA
Regulation Number868.5895
Classification Product Code
MOD  
Date Received06/14/2001
Decision Date 11/06/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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