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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Blood-Pressure, Extravascular
510(k) Number K921343
Device Name COBE PATIENT MONITORING PRODUCTS
Applicant
Cobe Cardiovascular, Inc.
14401 W. 65th Way
Arvada,  CO  80004
Applicant Contact MARY L ARMSTRONG
Correspondent
Cobe Cardiovascular, Inc.
14401 W. 65th Way
Arvada,  CO  80004
Correspondent Contact MARY L ARMSTRONG
Regulation Number870.2850
Classification Product Code
DRS  
Date Received03/19/1992
Decision Date 01/05/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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