FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
Fluobeam LX
K Number: K190891
·
Decision Jul 31, 2019
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
5
Applicant Total
3
Review Days
117
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Basic Information
- Device Name
- Fluobeam LX
- K Number
- K190891
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4550
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fluoptics
- Date Received
- April 5, 2019
- Decision Date
- July 31, 2019
- Product Code
- QDG
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| QDG | Parathyroid Autofluorescence Imaging Device | FDA class 2 | General, Plastic Surgery |
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