K223873
- 510(k) number
- K223873
- Device name
- Boppli Infant Blood Pressure Monitor
- Applicant
- Pyrames, Inc. CA · US
- Product code
- DXN — System, Measurement, Blood-Pressure, Non-Invasive
- Decision date
- 2023-09-29
- Date received
- 2022-12-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K223873.pdf
Official FDA record: K223873
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.