VERICIS CARDIOVASCULAR IMAGE AND INFORMATION SYSTEM, MODEL 4.0
FDA 510(k) clearance K051649 · decided 2005-08-02
Clearance details
- K-number
- K051649
- Device name
- VERICIS CARDIOVASCULAR IMAGE AND INFORMATION SYSTEM, MODEL 4.0
- Applicant
- Camtronics Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2005-06-21
- Decision date
- 2005-08-02
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- LLZ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Hartland, WI, US
- Third-party review
- No
- Expedited review
- No
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