TOSBEE
FDA 510(k) clearance K914583 · decided 1993-01-28
Clearance details
- K-number
- K914583
- Device name
- TOSBEE
- Applicant
- Toshiba America Medical Systems, In.C
- Decision
- Substantially Equivalent
- Date received
- 1991-10-16
- Decision date
- 1993-01-28
- Days to decision
- 470 days
- Clearance type
- Traditional
- Product code
- IYD
- Device class
- 2
- Regulation number
- 892.5900
- 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.