FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
21.3 INCH (54 CM) COLOR LCD MONITOR CCL358I2 (CL21358)
K Number: K133185
·
Decision Dec 3, 2013
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
11
Review Days
47
Basic Information
- Device Name
- 21.3 INCH (54 CM) COLOR LCD MONITOR CCL358I2 (CL21358)
- K Number
- K133185
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- JVC KENWOOD CORPORATION
- Date Received
- October 17, 2013
- Decision Date
- December 3, 2013
- 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 JVC KENWOOD CORPORATION
| K Number | Device Name | ||
|---|---|---|---|
| K151134 | 21.3 inch (54cm) Color LCD Monitor CCL210 (CL21210) | May 27, 2015 | Substantially Equivalent |
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| K143076 | 20.1 inch (51cm) Monochrome LCD Monitor ME205 (ML20205) | Nov 12, 2014 | Substantially Equivalent |
| K142536 | 21.5 inch (54.5 cm) Color LCD Monitor CCL220 (CL22220) | Oct 3, 2014 | Substantially Equivalent |
| K142540 | 24.1 inch (61.1 cm) Color LCD Monitor CCL244 (CL24244) | Oct 3, 2014 | Substantially Equivalent |
| K140214 | 30.0 INCH COLOR LCD MONITOR CCL650I2 (CL30650, MD302C6) | Feb 19, 2014 | Substantially Equivalent |
| K133686 | 21.3 INCH (54 CM) INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS35i2 (ML21035) | Jan 6, 2014 | Substantially Equivalent |
| K133511 | 21.3 INCH(54 CM) MONOCHROME LCD MONITOR MS25I2(ML21025) | Dec 19, 2013 | Substantially Equivalent |
| K133181 | 21.3 INCH (54 CM) COLOR LCD MONITOR CCL258I2 (CL21258) | Dec 3, 2013 | Substantially Equivalent |
| K131137 | 21.3 INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS55I2 (ML21055, MD211G5) | Jul 18, 2013 | Substantially Equivalent |