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FDA 510(k)

Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad)

Número K: K250979 · 2025-10-15

RequerenteZoll Circulation, Inc.
Data da decisão2025-10-15
Código do produtoNZE
Comité consultivoCV
DecisãoSubstantially Equivalent

Resumo do dispositivo

Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad) is the device name listed in this FDA 510(k) record. The listed applicant is Zoll Circulation, Inc.. It received FDA 510(k) clearance on 2025-10-15 under 510(k) number K250979. The device is classified under product code NZE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad)?

Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad) is a medical device that received FDA 510(k) clearance on 2025-10-15. The listed applicant is Zoll Circulation, Inc.. The 510(k) number is K250979.

When did Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad) receive FDA 510(k) clearance?

Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad) received FDA 510(k) clearance on 2025-10-15, under 510(k) number K250979.

Who is the listed applicant for Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad)?

The FDA 510(k) record lists Zoll Circulation, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad)?

The FDA product code for Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad) is NZE.

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Ver todos os 7 dispositivos →

Dispositivos Relacionados (Código: NZE)

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K240933CarbonCool® SystemGlobal Healthcare SG Sdn. BhdK231182Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management SystemZoll Circulation, Inc.K162523The IQool SystemBraincool AB

Fonte oficial

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