FUJINON ULTRASONIC PROCESSOR
FDA 510(k) clearance K111243 · decided 2011-05-16
Clearance details
- K-number
- K111243
- Device name
- FUJINON ULTRASONIC PROCESSOR
- Applicant
- Fujinon, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-05-03
- Decision date
- 2011-05-16
- Days to decision
- 13 days
- Clearance type
- Special
- Product code
- FDS
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Stamford, CT, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.