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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrocardiograph
510(k) Number K182093
Device Name ZOLL ECG Analysis Software
Applicant
ZOLL Manufacturing Corporation
121 Gamma Drive
pittsburgh,  PA  15238
Applicant Contact zachary nelson
Correspondent
ZOLL Manufacturing Corporation
121 Gamma Drive
pittsburgh,  PA  15238
Correspondent Contact zachary nelson
Regulation Number870.2340
Classification Product Code
DPS  
Date Received08/03/2018
Decision Date 01/28/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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