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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name hyperthermia monitor
510(k) Number K231182
Device Name Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System
Applicant
ZOLL Circulation, Inc
2000 Ringwood Avenue
San Jose,  CA  95131
Applicant Contact Sean Manning
Correspondent
ZOLL Circulation
2000 Ringwood Avenue
San Jose,  CA  91531
Correspondent Contact Sean Manning
Regulation Number870.5900
Classification Product Code
NZE  
Date Received04/26/2023
Decision Date 11/03/2023
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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