CarbonCool® System— 510(k) K240933
Substantially EquivalentGlobal Healthcare SG Sdn. Bhd
FDA 510(k) clearance K240933 for CarbonCool® System, Substantially Equivalent on 2025-03-18. Applicant: Global Healthcare SG Sdn. Bhd.
Clearance details
- Applicant
- Global Healthcare SG Sdn. Bhd
- Product code
- Code NZE
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Negeri Sembilan, MY
Data sourced from openFDA. This site is unofficial and independent of the FDA.