4CH FLEX SPEEDER
FDA 510(k) clearance K111251 · decided 2011-05-27
Clearance details
- K-number
- K111251
- Device name
- 4CH FLEX SPEEDER
- Applicant
- Toshiba Medical Systems Coporation, Japan
- Decision
- Substantially Equivalent
- Date received
- 2011-05-04
- Decision date
- 2011-05-27
- Days to decision
- 23 days
- Clearance type
- Special
- Product code
- MOS
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Tustin, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.