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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 K936067
Device Name ATLAS 1.0 DIAGNOSTIC ULTRASOUND SYSTEM
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 Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received12/21/1993
Decision Date 10/27/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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