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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Echocardiograph
510(k) Number K031148
Device Name IN-VISION IMAGING SYSTEM
Applicant
Jomed, Inc.
2870 Kilgore Rd..
Rancho Cordova,,  CA  95670
Applicant Contact LORRAINE W HUFFMAN
Correspondent
Jomed, Inc.
2870 Kilgore Rd..
Rancho Cordova,,  CA  95670
Correspondent Contact LORRAINE W HUFFMAN
Regulation Number870.2330
Classification Product Code
DXK  
Date Received04/10/2003
Decision Date 05/28/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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