K233253
- 510(k) number
- K233253
- Device name
- eCARTv5 Clinical Deterioration Suite (eCART)
- Applicant
- Agilemd, Inc. CA · US
- Product code
- QNL — Medium-Term Adjunctive Predictive Cardiovascular Ind
- Decision date
- 2024-06-21
- Date received
- 2023-09-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K233253.pdf
Official FDA record: K233253
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.