Leica FL400
FDA 510(k) clearance DEN180024 · decided 2019-03-28
Clearance details
- K-number
- DEN180024
- Device name
- Leica FL400
- Applicant
- Leica Microsystems (Schweiz) AG
- Decision
- Unknown
- Date received
- 2018-04-27
- Decision date
- 2019-03-28
- Days to decision
- 335 days
- Clearance type
- Direct
- Product code
- QFX
- Device class
- 2
- Regulation number
- 882.4950
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Heerbrugg, CH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.