INF 4160 PLUS, MODEL D-FJ31F
FDA 510(k) clearance K092780 · decided 2010-01-07
Clearance details
- K-number
- K092780
- Device name
- INF 4160 PLUS, MODEL D-FJ31F
- Applicant
- Fuji Dynamics Limited
- Decision
- Substantially Equivalent
- Date received
- 2009-09-10
- Decision date
- 2010-01-07
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- LIH
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Kowloon, Hong Kong, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.