MODULEAF
FDA 510(k) clearance K030609 · decided 2003-03-17
Clearance details
- K-number
- K030609
- Device name
- MODULEAF
- Applicant
- Mrc Systems GmbH
- Decision
- Substantially Equivalent
- Date received
- 2003-02-26
- Decision date
- 2003-03-17
- Days to decision
- 19 days
- Clearance type
- Special
- Product code
- IXI
- Device class
- 2
- Regulation number
- 892.5710
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Heidelberg, DE
- Third-party review
- No
- Expedited review
- No
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