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FDA 510(k) Application Details - K032439
Device Classification Name
Automated External Defibrillators (Non-Wearable)
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510(K) Number
K032439
Device Name
Automated External Defibrillators (Non-Wearable)
Applicant
ZOLL MEDICAL CORP.
269 MILL ROAD
CHELMSFORD, MA 01824-4105 US
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Contact
SCOTT AUGUST
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Regulation Number
870.5310
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Classification Product Code
MKJ
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More FDA Info for this Product Code
Date Received
08/07/2003
Decision Date
11/05/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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