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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 K900459
Device Name APPLICARD (EKG)
Applicant
Medi-Globe Corp.
P.O. Box 18914
Irvine,  CA  92713
Applicant Contact STEFAN WOHNHAS
Correspondent
Medi-Globe Corp.
P.O. Box 18914
Irvine,  CA  92713
Correspondent Contact STEFAN WOHNHAS
Regulation Number870.4330
Classification Product Code
DRY  
Date Received01/30/1990
Decision Date 07/31/1990
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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