K242066
- 510(k) number
- K242066
- Device name
- iSage Rx
- Applicant
- Amalgam Rx, Inc. DE · US
- Product code
- NDC — Calculator, Drug Dose
- Decision date
- 2024-08-21
- Date received
- 2024-07-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K242066.pdf
Official FDA record: K242066
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.