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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Pulmonary Function Data
510(k) Number K900696
Device Name BIORE CP-100 CARDIOPULMONARY MONITOR
Applicant
Bicore Monitoring Systems
2 Faraday
Irvine,  CA  92718
Applicant Contact DAVID B VIELE
Correspondent
Bicore Monitoring Systems
2 Faraday
Irvine,  CA  92718
Correspondent Contact DAVID B VIELE
Regulation Number868.1880
Classification Product Code
BZC  
Date Received02/13/1990
Decision Date 11/29/1990
Decision Substantially Equivalent (SESE)
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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