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FDA 510(k) Application Details - K041026
Device Classification Name
Electrode, Electrocardiograph
More FDA Info for this Device
510(K) Number
K041026
Device Name
Electrode, Electrocardiograph
Applicant
AMBU, INC.
611 NORTH HAMMONDS FERRY ROAD
LINTHICUM, MD 21090-1356 US
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Contact
SANJAY PARIKH
Other 510(k) Applications for this Contact
Regulation Number
870.2360
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Classification Product Code
DRX
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More FDA Info for this Product Code
Date Received
04/21/2004
Decision Date
06/28/2004
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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