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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K881475
Device Name SYSTEM5RH STATIONARY EXERCISE BICYCLE
Applicant
Combi Co. Ltd., C/O Mitsui & Co. U.S.A., Inc.
200 Public Sq.
Suite 29-5500
Cleveland,  OH  44114
Applicant Contact RICH GALLAND
Correspondent
Combi Co. Ltd., C/O Mitsui & Co. U.S.A., Inc.
200 Public Sq.
Suite 29-5500
Cleveland,  OH  44114
Correspondent Contact RICH GALLAND
Regulation Number870.2340
Classification Product Code
DPS  
Date Received04/07/1988
Decision Date 08/02/1988
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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