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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
510(k) Number K852124
Device Name HEMATOCRIT-SATURATION MONITOR HSM-100
Applicant
American Bentley
P.O. Box 19522
Irvine,  CA  92713
Applicant Contact DONALD A RAIBLE
Correspondent
American Bentley
P.O. Box 19522
Irvine,  CA  92713
Correspondent Contact DONALD A RAIBLE
Regulation Number870.4330
Classification Product Code
DRY  
Date Received05/15/1985
Decision Date 09/16/1985
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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