CarbonCool® System— 510(k) K240933

Name: FDA 510(k) clearance K240933
Creator: U.S. Food and Drug Administration
Published: 2025-03-18

Substantially Equivalent

Global Healthcare SG Sdn. Bhd

FDA 510(k) clearance K240933 for CarbonCool® System, Substantially Equivalent on 2025-03-18. Applicant: Global Healthcare SG Sdn. Bhd. Device class: 2.

Clearance details

Applicant: Global Healthcare SG Sdn. Bhd
Product code: Code NZE
Device class: Class 2
Regulation: 21 CFR 870.5900
Advisory panel: Cardiovascular
Date received: 2024-04-05
Decision date: 2025-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Negeri Sembilan, MY

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.