K251045
- 510(k) number
- K251045
- Device name
- Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U1683S-C51N); Disposable Neonatal NIBP Cuff (U1684S-C51N); Disposable Neonatal NIBP Cuff (U1685S-C51N)
- Applicant
- Unimed Medical Supplies, Inc. CN
- Product code
- DXQ — Blood Pressure Cuff
- Decision date
- 2025-07-15
- Date received
- 2025-04-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K251045.pdf
Official FDA record: K251045
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.