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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K002388
Device Name EHC500 DESKTOP PATIENT STATION, MODEL EHC500
Applicant
CYBERCARE, INC.
7840 ROSWELL RD., SUITE 320
ATLANTA,  GA  30350
Applicant Contact J. TERRY DRURY
Correspondent
CYBERCARE, INC.
7840 ROSWELL RD., SUITE 320
ATLANTA,  GA  30350
Correspondent Contact J. TERRY DRURY
Regulation Number870.1130
Classification Product Code
DXN  
Date Received08/04/2000
Decision Date 08/25/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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