FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
AViTA Pulse Oximeter (SP62B)
K Number: K242455
·
Decision Feb 19, 2025
Classifications
1
FEI Numbers
403
Registration Numbers
403
Same Product Code
711
Applicant Total
4
Review Days
184
Basic Information
- Device Name
- AViTA Pulse Oximeter (SP62B)
- K Number
- K242455
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- AViTA Corporation
- Date Received
- August 19, 2024
- Decision Date
- February 19, 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 |
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