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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 K250979
Device Name Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad)
Applicant
Zoll Circulation, Inc.
2000 Ringwood Ave.
San Jose,  CA  95131
Applicant Contact Riki Chaudhary
Correspondent
Zoll Circulation, Inc.
2000 Ringwood Ave.
San Jose,  CA  95131
Correspondent Contact Riki Chaudhary
Regulation Number870.5900
Classification Product Code
NZE  
Subsequent Product Code
DWJ  
Date Received03/31/2025
Decision Date 10/15/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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