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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 K072752
Device Name BP LIMBO XL, BPTANGO XL, BP SALSA XL
Applicant
DATADANCER MEDICAL SYSTEMS
1644 LAUREL STREET
CHICO,  CA  95928
Applicant Contact MICHAEL KOHUT
Correspondent
DATADANCER MEDICAL SYSTEMS
1644 LAUREL STREET
CHICO,  CA  95928
Correspondent Contact MICHAEL KOHUT
Regulation Number870.1425
Classification Product Code
DQK  
Subsequent Product Code
DXN  
Date Received09/27/2007
Decision Date 10/31/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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