K240601
- 510(k) number
- K240601
- Device name
- SnapshotNIR model KD205
- Applicant
- Kent Imaging, Inc. CA
- Product code
- MUD — Oximeter, Tissue Saturation
- Decision date
- 2024-04-02
- Date received
- 2024-03-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K240601.pdf
Official FDA record: K240601
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.