FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
2MP Color LCD Monitor CCL214 (CL21214)
K Number: K161895
·
Decision Sep 8, 2016
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
134
Applicant Total
22
Review Days
59
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Basic Information
- Device Name
- 2MP Color LCD Monitor CCL214 (CL21214)
- K Number
- K161895
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Jvckenwood Corporation
- Date Received
- July 11, 2016
- Decision Date
- September 8, 2016
- Product Code
- PGY
- 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 |
|---|---|---|---|
| PGY | Display, Diagnostic Radiology | FDA class 2 | Radiology |
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|---|---|---|---|
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| K212985 | 6MP Color LCD Monitor CL-S600 | Dec 16, 2021 | Substantially Equivalent |
| K203733 | 12MP Color Digital Mammography LCD Monitor CL-S1200 | Jun 29, 2021 | Substantially Equivalent |
| K210345 | 2MP Monochrome LCD Monitor MS-S200 | Apr 23, 2021 | Substantially Equivalent |
| K200161 | 3MP Monochrome Digital Mammography LCD Monitor MS-S300 | Feb 21, 2020 | Substantially Equivalent |
| K191137 | 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500 | Jul 2, 2019 | Substantially Equivalent |
| K182539 | 2MP Color LCD Monitor CL-R211 | Oct 3, 2018 | Substantially Equivalent |
| K173434 | 2MP Color LCD Monitor CL-S200, 3MP Color LCD Monitor CL-S300 | Dec 14, 2017 | Substantially Equivalent |
| K160326 | 5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550) | Feb 23, 2016 | Substantially Equivalent |