Disposable Neonatal NIBP Cuff (4 models)— 510(k) K251045
Substantially EquivalentUnimed Medical Supplies, Inc.
FDA 510(k) clearance K251045 for Disposable Neonatal NIBP Cuff (4 models), Substantially Equivalent on 2025-07-15. Applicant: Unimed Medical Supplies, Inc.. Device class: 2.
Clearance details
- Device name as filed
- 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.
- Product code
- Code DXQ
- Device class
- Class 2
- Regulation
- 21 CFR 870.1120
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code DXQ
view all- K254287 — Medline Reusable Blood Pressure Cuff
- K260747 — YP-710T Series NIBP Cuff; YP-840T Series Disposable Cuff
- K253089 — NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)
- K253964 — Disposable Neonatal NIBP Cuff (U1681S-C51N)
- K251745 — Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)
More clearances from Unimed Medical Supplies, Inc.
view all- K253162 — Temperature probes (5 models)
- K260931 — Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)
- K251691 — Unimed Reusable SpO2 Sensors (-08 Series) (4 models)
- K251696 — Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48) +1 more
- K251693 — Unimed Reusable SpO2 Sensors (-75 Series) (5 models)
Data sourced from openFDA. This site is unofficial and independent of the FDA.