FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
deepLive
K Number: K240610
·
Decision Jul 9, 2024
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
45
Applicant Total
2
Review Days
126
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Basic Information
- Device Name
- deepLive
- K Number
- K240610
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Damae Medical
- Date Received
- March 5, 2024
- Decision Date
- July 9, 2024
- Product Code
- NQQ
- Advisory Committee
- Radiology
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| NQQ | System, Imaging, Optical Coherence Tomography (Oct) | FDA class 2 | Radiology |
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Other Clearances by Damae Medical
| K Number | Device Name | ||
|---|---|---|---|
| K252851 | deepLive (OSP12 + DMS) | Oct 7, 2025 | Substantially Equivalent |