Disposable Neonatal NIBP Cuff (U1681S-C51N)
FDA 510(k) clearance K253964 · decided 2026-01-09
Clearance details
- K-number
- K253964
- Device name
- Disposable Neonatal NIBP Cuff (U1681S-C51N)
- Applicant
- Unimed Medical Supplies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-12-11
- Decision date
- 2026-01-09
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- DXQ
- Device class
- 2
- Regulation number
- 870.1120
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.