FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANNE Limb
K Number: K240305
·
Decision May 28, 2024
Classifications
1
FEI Numbers
400
Registration Numbers
400
Same Product Code
725
Applicant Total
5
Review Days
116
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Basic Information
- Device Name
- ANNE Limb
- K Number
- K240305
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sibel Health, Inc.
- Date Received
- February 2, 2024
- Decision Date
- May 28, 2024
- 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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