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FDA 510(k) Application Details - K972241
Device Classification Name
Automated External Defibrillators (Non-Wearable)
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510(K) Number
K972241
Device Name
Automated External Defibrillators (Non-Wearable)
Applicant
ZOLL MEDICAL CORP.
32 SECOND AVE.
BURLINGTON, MA 01803 US
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Contact
MAURA MCGUIRE
Other 510(k) Applications for this Contact
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
06/16/1997
Decision Date
03/16/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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