510(k) K182539
- Device
- 2MP Color LCD Monitor CL-R211
- Applicant
- JVC Kenwood Corporation
- 510(k) number
- K182539
- Product code
- PGY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-10-03
- Date received
- 2018-09-14
- Regulation
- 892.2050
- Classification name
- Display, Diagnostic Radiology
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Masafumi Yugami
- Address
- 3-12, Moriya-Cho, Kanagawa-Ku Yokohama JP 221-0022 221-0022
FDA Registration Numbers
- 3010043098
- 3007817002
- 3004082357
- 3024137003
- 3003032840
- 9613188
- 3024689474
- 3002808157
- 3016696283
- 3024897454
- 1000207387
- 3013084615
- 3004434200
- 3008481104
- 1000181154
- 3013501671
- 3009553444
- 3015976667
- 3006615210
- 3031232523
- 3000237660
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00046838078897 | JVC | JVC KENWOOD CORPORATION | 2018-12-28 |
Legacy Summary
summary
FDA Review
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