LUCAS 2
FDA 510(k) clearance K090422 · decided 2009-06-17
Clearance details
- K-number
- K090422
- Device name
- LUCAS 2
- Applicant
- Jolife AB
- Decision
- Substantially Equivalent
- Date received
- 2009-02-18
- Decision date
- 2009-06-17
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- DRM
- Device class
- 2
- Regulation number
- 870.5200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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| MODIFICATION TO LUCAS (K062401) | Jolife AB | 2006-09-28 |