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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Display, Cathode-Ray Tube, Medical
510(k) Number K131919
Device Name ZOLL EPCR IOS
Applicant
ZOLL Medical Corporation
269 Mill Rd.
Chelsmford,  MA  01824
Applicant Contact SHANNON DUHAMEL
Correspondent
ZOLL Medical Corporation
269 Mill Rd.
Chelsmford,  MA  01824
Correspondent Contact SHANNON DUHAMEL
Regulation Number870.2450
Classification Product Code
DXJ  
Date Received06/26/2013
Decision Date 12/17/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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