K240933
- 510(k) number
- K240933
- Device name
- CarbonCool® System
- Applicant
- Global Healthcare SG Sdn. Bhd MY
- Product code
- NZE — Hyperthermia Monitor
- Decision date
- 2025-03-18
- Date received
- 2024-04-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K240933.pdf
Official FDA record: K240933
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.