K231256
- 510(k) number
- K231256
- Device name
- Carecube Negative Pressure Isolation Chamber
- Applicant
- Carecubes, Inc. CA · US
- Product code
- LGM — Chamber, Patient Isolation
- Decision date
- 2024-01-03
- Date received
- 2023-05-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K231256.pdf
Official FDA record: K231256
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.