Unimed Reusable SpO2 Sensors (-08 Series) (4 models)— 510(k) K251691
Substantially EquivalentUnimed Medical Supplies, Inc.
FDA 510(k) clearance K251691 for Unimed Reusable SpO2 Sensors (-08 Series) (4 models), Substantially Equivalent on 2025-12-01. Applicant: Unimed Medical Supplies, Inc.. Device class: 2.
Clearance details
- Device name as filed
- Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08)
- Applicant
- Unimed Medical Supplies, Inc.
- Product code
- Code DQA
- Device class
- Class 2
- Regulation
- 21 CFR 870.2700
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code DQA
view all- K252821 — Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)
- K252655 — Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)
- K253887 — Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)
- K260931 — Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)
- K252448 — AViTA Pulse Oximeter (SP61)
More clearances from Unimed Medical Supplies, Inc.
view all- K253162 — Temperature probes (5 models)
- K253964 — Disposable Neonatal NIBP Cuff (U1681S-C51N)
- K251696 — Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48) +1 more
- K251693 — Unimed Reusable SpO2 Sensors (-75 Series) (5 models)
- K251695 — Unimed Reusable SpO2 Sensors (-06 Series) (3 models)
Adverse events under product code DQA
product code DQA- Death
- 66
- Malfunction
- 2,867
- Other
- 1
- Total
- 2,934
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.