FDR SE Lite— 510(k) K192440
Substantially EquivalentFujifilm Corporation
FDA 510(k) clearance K192440 for FDR SE Lite, Substantially Equivalent on 2019-11-01. Applicant: Fujifilm Corporation. Device class: 2.
Clearance details
- Applicant
- Fujifilm Corporation
- Product code
- Code MQB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1680
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ashigarakami-Gun Kanagawa, JP
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