Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0
FDA 510(k) clearance K203717 · decided 2021-06-30
Clearance details
- K-number
- K203717
- Device name
- Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0
- Applicant
- Fujifilm Corporaton
- Decision
- Substantially Equivalent
- Date received
- 2020-12-21
- Decision date
- 2021-06-30
- Days to decision
- 191 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Ashigara Kami-Gun, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.