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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 Echo, Ultrasonic
510(k) Number K961073
Device Name ATLAS 2.0 & HITACHI 2.0 (A TRADE NAME SUBJECT TO CHANGE)
Applicant
Atlantis Diagnostics Intl., Inc.
18939 120th Ave. NE
Suite 111
Bothell,  WA  98011
Applicant Contact TERRENCE J SWEENEY
Correspondent
Atlantis Diagnostics Intl., Inc.
18939 120th Ave. NE
Suite 111
Bothell,  WA  98011
Correspondent Contact TERRENCE J SWEENEY
Regulation Number892.1560
Classification Product Code
IYO  
Date Received03/18/1996
Decision Date 02/19/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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