K240100
- 510(k) number
- K240100
- Device name
- SAM Model 9-10000
- Applicant
- Snap Diagnostics, LLC IL · US
- Product code
- MNR — Ventilatory Effort Recorder
- Decision date
- 2024-06-04
- Date received
- 2024-01-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K240100.pdf
Official FDA record: K240100
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.