Data / Medical devices / Japan / JVCKENWOOD Corporation
JVCKENWOOD Corporation: FDA-registered device maker in Yokohama-shi Kanagawa, Japan, 9 510(k) clearances
JVCKENWOOD Corporation is registered with the FDA (registration 1000207387) in Yokohama-shi Kanagawa, Japan. It lists 1 device type. The FDA files 9 510(k) clearances under its listings, the newest dated August 1, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1000207387
- Address
- 3-12, Moriya-cho, Kanagawa-ku, Yokohama-shi Kanagawa, Japan, 221-0022
- Owner or operator
- JVCKENWOOD Corporation (10044588)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- December 14, 2017
- Registered through
- 2026
- Brand names listed
- CL-R211, CL-R813, CL-S1200, CL-S200, CL-S300, CL-S301, CL-S500, CL-S600 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Display, Diagnostic Radiology | PGY | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 1, 2024 | K241105 | 3MP Color LCD Monitor (CL-S301) | PGY | Substantially Equivalent | Jvckenwood Corporation | accessdata.fda.gov |
| December 21, 2022 | K222864 | 8MP Color LCD Monitor CL-R813 | PGY | Substantially Equivalent | Jvckenwood Corporation | accessdata.fda.gov |
| December 16, 2021 | K212985 | 6MP Color LCD Monitor CL-S600 | PGY | Substantially Equivalent | Jvckenwood Corporation | accessdata.fda.gov |
| June 29, 2021 | K203733 | 12MP Color Digital Mammography LCD Monitor CL-S1200 | PGY | Substantially Equivalent | Jvckenwood Corporation | accessdata.fda.gov |
| April 23, 2021 | K210345 | 2MP Monochrome LCD Monitor MS-S200 | PGY | Substantially Equivalent | Jvckenwood Corporation | accessdata.fda.gov |
| February 21, 2020 | K200161 | 3MP Monochrome Digital Mammography LCD Monitor MS-S300 | PGY | Substantially Equivalent | Jvckenwood Corporation | accessdata.fda.gov |
| July 2, 2019 | K191137 | 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500 | PGY | Substantially Equivalent | Jvckenwood Corporation | accessdata.fda.gov |
| October 3, 2018 | K182539 | 2MP Color LCD Monitor CL-R211 | PGY | Substantially Equivalent | Jvckenwood Corporation | accessdata.fda.gov |
| December 14, 2017 | K173434 | 2MP Color LCD Monitor CL-S200, 3MP Color LCD Monitor CL-S300 | PGY | Substantially Equivalent | Jvckenwood Corporation | accessdata.fda.gov |
Compare with other makers
Updated August 1, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.