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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, network and communication, physiological monitors
510(k) Number K061994
Device Name WEB VIEWER, POCKET VIEWER AND CELLULAR VIEWER WITH L- WEB05 SOFTWARE
Applicant
GE HEALTHCARE
86 PILGRIM ROAD
needham,  MA  02492
Applicant Contact joel kent
Correspondent
GE HEALTHCARE
86 PILGRIM ROAD
needham,  MA  02492
Correspondent Contact joel kent
Regulation Number870.2300
Classification Product Code
MSX  
Date Received07/14/2006
Decision Date 08/11/2006
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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