K253964
- 510(k) number
- K253964
- Device name
- Disposable Neonatal NIBP Cuff (U1681S-C51N)
- Applicant
- Unimed Medical Supplies, Inc. CN
- Product code
- DXQ — Blood Pressure Cuff
- Decision date
- 2026-01-09
- Date received
- 2025-12-11
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K253964.pdf
Official FDA record: K253964
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.