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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrocardiograph
510(k) Number K052944
Device Name AMBU WHITE SENSOR CFM, CFL
Applicant
AMBU A/S
6740 BAYMEADOW DR.
GLEN BURNIE,  MD  21060
Applicant Contact SANJAY PARIKH
Correspondent
AMBU A/S
6740 BAYMEADOW DR.
GLEN BURNIE,  MD  21060
Correspondent Contact SANJAY PARIKH
Regulation Number870.2360
Classification Product Code
DRX  
Date Received10/20/2005
Decision Date 10/25/2006
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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