FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
20.1-INCH (51CM) COLOR LCD MONITOR CDL2009A (CCL204)
K Number: K061061
·
Decision Jun 7, 2006
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
2
Review Days
51
Basic Information
- Device Name
- 20.1-INCH (51CM) COLOR LCD MONITOR CDL2009A (CCL204)
- K Number
- K061061
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- TOKOTU ELECTRIC CO., LTD.
- Date Received
- April 17, 2006
- Decision Date
- June 7, 2006
- Product Code
- LLZ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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Other Clearances by TOKOTU ELECTRIC CO., LTD.
| K Number | Device Name | ||
|---|---|---|---|
| K081242 | 21.3 INCH (53CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS51I2, (MDL2123A) | Jun 11, 2008 | Substantially Equivalent |