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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 K100129
Device Name AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X
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 Received01/19/2010
Decision Date 06/11/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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