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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K905248
Device Name NOVA MICROSONICS CAPRICORN DIGITAL IMAGE SYSTEMS
Applicant
Advanced Technology Laboratories, Inc.
22100 Bothell Everett Hwy.
P.O. Box 3003
Bothell,  WA  98041
Applicant Contact TERRENCE J SWEENEY
Correspondent
Advanced Technology Laboratories, Inc.
22100 Bothell Everett Hwy.
P.O. Box 3003
Bothell,  WA  98041
Correspondent Contact TERRENCE J SWEENEY
Regulation Number870.1425
Classification Product Code
DQK  
Date Received11/21/1990
Decision Date 02/28/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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