35/CD CINECONVERTER
FDA 510(k) clearance K001841 · decided 2000-11-15
Clearance details
- K-number
- K001841
- Device name
- 35/CD CINECONVERTER
- Applicant
- Tagarno A/S
- Decision
- Substantially Equivalent
- Date received
- 2000-06-19
- Decision date
- 2000-11-15
- Days to decision
- 149 days
- Clearance type
- Traditional
- Product code
- LMA
- Device class
- 2
- Regulation number
- 892.2030
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Horsens, DK
- Third-party review
- No
- Expedited review
- No
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| DIGITAL IMAGER (K032022) | Pyramid Medical, Inc. | 2003-09-02 |
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| FULCRUM (K021949) | Howtek, Inc. | 2002-08-12 |
Recalls involving this device
No recalls on record reference this clearance.