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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(k) Number K983928
Device Name KODAK HOME HEALTH MONITORING SYSTEM
Applicant
Eastman Kodak Company
901 Elmgrove Rd.
Rochester,  NY  14653 -4757
Applicant Contact JUDITH A WALLACE
Correspondent
Eastman Kodak Company
901 Elmgrove Rd.
Rochester,  NY  14653 -4757
Correspondent Contact JUDITH A WALLACE
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Codes
DRG   DXN  
Date Received11/05/1998
Decision Date 02/11/2000
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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