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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(k) Number K130208
Device Name BERNOULLI ENTERPRISE SOFTWARE
Applicant
Cardiopulmonary Corp.
200 Cascade Blvd.
Milford,  CT  06460
Applicant Contact UREY KANG
Correspondent
Cardiopulmonary Corp.
200 Cascade Blvd.
Milford,  CT  06460
Correspondent Contact UREY KANG
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
MSX   PFY  
Date Received01/28/2013
Decision Date 12/20/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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