FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Pulse Oximeter
K Number: K250837
·
Decision Sep 25, 2025
Classifications
1
FEI Numbers
400
Registration Numbers
400
Same Product Code
725
Applicant Total
3
Review Days
189
Basic Information
- Device Name
- Pulse Oximeter
- K Number
- K250837
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shanghai Berry Electronic Tech Co., Ltd.
- Date Received
- March 20, 2025
- Decision Date
- September 25, 2025
- Product Code
- DQA
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DQA | Oximeter | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DQA), ordered by most recent decision date.
Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)
FDA 510(k)
FDA Class 2
·Cardiovascular
Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)
FDA 510(k)
FDA Class 2
·Cardiovascular
Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)
FDA 510(k)
FDA Class 2
·Cardiovascular
Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)
FDA 510(k)
FDA Class 2
·Cardiovascular
AViTA Pulse Oximeter (SP61)
FDA 510(k)
FDA Class 2
·Cardiovascular
YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)
FDA 510(k)
FDA Class 2
·Cardiovascular