K242842
- 510(k) number
- K242842
- Device name
- ANNE View, Central Hub
- Applicant
- Sibel Health, Inc. IL · US
- Product code
- MSX — System, Network And Communication, Physiological Mon
- Decision date
- 2025-01-08
- Date received
- 2024-09-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.7 MB · U.S. public domain
Also available from FDA: K242842.pdf
Official FDA record: K242842
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.