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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, measurement, blood-pressure, non-invasive
510(k) Number K122129
Device Name SPHYGMOCOR XCEL
Applicant
ATCOR MEDICAL
11/1059-1063 VICTORIA
ROAD
WEST RYDE NSW,  AU 2114
Applicant Contact JOHN ABRAM
Correspondent
ATCOR MEDICAL
11/1059-1063 VICTORIA
ROAD
WEST RYDE NSW,  AU 2114
Correspondent Contact JOHN ABRAM
Regulation Number870.1130
Classification Product Code
DXN  
Subsequent Product Code
DSK  
Date Received07/18/2012
Decision Date 11/16/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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