K232502
- 510(k) number
- K232502
- Device name
- Cocoon Convective Warming System, Model CWS7000
- Applicant
- Care Essentials Pty, Ltd. AU
- Product code
- DWJ — System, Thermal Regulating
- Decision date
- 2024-02-21
- Date received
- 2023-08-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K232502.pdf
Official FDA record: K232502
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.