FDA 510(k)
FDA class 2
Unknown
🇨🇭 Switzerland
Leica FL400
K Number: DEN180024
·
Decision Mar 28, 2019
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
4
Applicant Total
4
Review Days
335
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Basic Information
- Device Name
- Leica FL400
- K Number
- DEN180024
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 882.4950
- Medical Specialty
- Neurology
- Decision
- Unknown
- Applicant
- Leica Microsystems (Schweiz) AG
- Date Received
- April 27, 2018
- Decision Date
- March 28, 2019
- Product Code
- QFX
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| QFX | Diagnostic Neurosurgical Microscope Filter | FDA class 2 | Neurology |
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