FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Avidhrt Sense SpO2
K Number: K241086
·
Decision May 9, 2025
Classifications
1
FEI Numbers
403
Registration Numbers
403
Same Product Code
711
Applicant Total
1
Review Days
385
Basic Information
- Device Name
- Avidhrt Sense SpO2
- K Number
- K241086
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Avidhrt Inc.
- Date Received
- April 19, 2024
- Decision Date
- May 9, 2025
- Product Code
- DQA
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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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