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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K973922
Device Name ARCHIMED 4210 AND 4220
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
Classification Product Code
LOS
Date Received10/15/1997
Decision Date 05/12/1998
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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