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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K041031
Device Name CARDIOSTATION-100 (CS-100)
Applicant
Us Clover Co.
17800 Castleton St.
Suite 415
City Of Industry,  CA  91748
Applicant Contact CECILIA L YU
Correspondent
Us Clover Co.
17800 Castleton St.
Suite 415
City Of Industry,  CA  91748
Correspondent Contact CECILIA L YU
Regulation Number870.1425
Classification Product Code
DQK  
Date Received04/21/2004
Decision Date 01/26/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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