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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrocardiograph
510(k) Number K060167
Device Name ATRIA 3100, ATRIA 6100
Original Applicant
3303 monte villa pkwy.
bothell,  WA  98021
Original Contact cheryl shea
Regulation Number870.2340
Classification Product Code
Date Received01/24/2006
Decision Date 04/19/2006
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No