FDA 510(k)

CarbonCool® System

K-Number: K240933 · 2025-03-18

Decision Date2025-03-18

Product CodeNZE

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CarbonCool® System is the device name listed in this FDA 510(k) record. The listed applicant is Global Healthcare SG Sdn. Bhd. It received FDA 510(k) clearance on 2025-03-18 under 510(k) number K240933. The device is classified under product code NZE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CarbonCool® System?

CarbonCool® System is a medical device that received FDA 510(k) clearance on 2025-03-18. The listed applicant is Global Healthcare SG Sdn. Bhd. The 510(k) number is K240933.

When did CarbonCool® System receive FDA 510(k) clearance?

CarbonCool® System received FDA 510(k) clearance on 2025-03-18, under 510(k) number K240933.

Who is the listed applicant for CarbonCool® System?

The FDA 510(k) record lists Global Healthcare SG Sdn. Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CarbonCool® System?

The FDA product code for CarbonCool® System is NZE.

Related Devices (Code: NZE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250979Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad)Zoll Circulation, Inc.K231182Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management SystemZoll Circulation, Inc.K162523The IQool SystemBraincool AB

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.