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FDA 510(k) Application Details - K053550
Device Classification Name
Electrode, Electrocardiograph
More FDA Info for this Device
510(K) Number
K053550
Device Name
Electrode, Electrocardiograph
Applicant
AMBU A/S
6740 BAYMEADOW DR.
GLEN BURNIE, MD 21060 US
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Contact
SANJAY PARIKH
Other 510(k) Applications for this Contact
Regulation Number
870.2360
More FDA Info for this Regulation Number
Classification Product Code
DRX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/20/2005
Decision Date
10/25/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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