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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dc-defibrillator, low-energy, (including paddles)
510(k) Number K042302
Device Name ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED ELECTRODES, ZOLL AUTOCLAVABLE
Applicant
ZOLL MEDICAL CORP.
269 MILL ROAD
CHELMSFORD,  MA  01824 -4105
Applicant Contact SEAN REYNOLDS
Correspondent
ZOLL MEDICAL CORP.
269 MILL ROAD
CHELMSFORD,  MA  01824 -4105
Correspondent Contact SEAN REYNOLDS
Regulation Number870.5300
Classification Product Code
LDD  
Date Received08/25/2004
Decision Date 10/26/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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