K242809
- 510(k) number
- K242809
- Device name
- Ascent Cardiorespiratory Diagnostic Software
- Applicant
- Medical Graphics Corporation MN · US
- Product code
- BTY — Calculator, Predicted Values, Pulmonary Function
- Decision date
- 2024-10-17
- Date received
- 2024-09-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K242809.pdf
Official FDA record: K242809
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.