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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, imaging, pulsed doppler, ultrasonic
510(k) Number K994369
Device Name 7250 (MEGAS)
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 Number892.1550
Classification Product Code
IYN  
Subsequent Product Code
IYO  
Date Received12/27/1999
Decision Date 02/24/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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