K232638
- 510(k) number
- K232638
- Device name
- FilteredFlo Warming Blankets
- Applicant
- Iob Medical, Inc. MD · US
- Product code
- DWJ — System, Thermal Regulating
- Decision date
- 2023-10-24
- Date received
- 2023-08-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K232638.pdf
Official FDA record: K232638
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.