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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K001894
Device Name MODIFICATION TO E-SCAN
Applicant
BIOSOUND ESAOTE, INC.
8000 CASTLEWAY DR.
INDIANAPOLIS,  IN  46250
Applicant Contact COLLEEN HITTLE
Correspondent
BIOSOUND ESAOTE, INC.
8000 CASTLEWAY DR.
INDIANAPOLIS,  IN  46250
Correspondent Contact COLLEEN HITTLE
Regulation Number892.1000
Classification Product Code
LNH  
Date Received06/21/2000
Decision Date 07/06/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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