FOCAL SIM
FDA 510(k) clearance K013112 · decided 2001-12-05
Clearance details
- K-number
- K013112
- Device name
- FOCAL SIM
- Applicant
- Computerized Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-09-18
- Decision date
- 2001-12-05
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- MUJ
- Device class
- 2
- Regulation number
- 892.5050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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