FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Pulse Oximeter ( PO2, PO2A, PO2B)
K Number: K242876
·
Decision Feb 28, 2025
Classifications
1
FEI Numbers
403
Registration Numbers
403
Same Product Code
711
Applicant Total
5
Review Days
158
Basic Information
- Device Name
- Pulse Oximeter ( PO2, PO2A, PO2B)
- K Number
- K242876
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shenzhen Viatom Technology Co., Ltd.
- Date Received
- September 23, 2024
- Decision Date
- February 28, 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.
Avidhrt Sense SpO2
FDA 510(k)
FDA Class 2
·Cardiovascular
Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)
FDA 510(k)
FDA Class 2
·Cardiovascular
Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U410-91)
FDA 510(k)
FDA Class 2
·Cardiovascular
AViTA Pulse Oximeter (SP62B)
FDA 510(k)
FDA Class 2
·Cardiovascular
Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2 Sensors (U403-254); Unimed Reusable Finger Clip SpO2 Sensors (U103-254); Unimed Reusable Finger Clip SpO2 Sensors (U403-125)
FDA 510(k)
FDA Class 2
·Cardiovascular
Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)
FDA 510(k)
FDA Class 2
·Cardiovascular