Data / Medical devices / Standard Polysomnograph With Electroencephalograph / Japan
FDA-registered makers of Standard Polysomnograph With Electroencephalograph in Japan: 5 establishments
5 establishments in Japan are registered with the FDA to make Standard Polysomnograph With Electroencephalograph (product code OLV). 4 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Standard Polysomnograph With Electroencephalograph
- Product code
- OLV
- Country
- Japan
Makers of Standard Polysomnograph With Electroencephalograph in Japan
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Nihon Kohden Corp. | SHINJUKU-KU Tokyo, Japan | Specification developer | 5 | January 11, 2008 | 0 | 0 | 0 | api.fda.gov |
| Nihon Kohden Tomioka Production Center | TOMIOKA-SHI Gunma, Japan | Manufacturer | 5 | January 11, 2008 | 0 | 0 | 0 | api.fda.gov |
| Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology Center | Tokorozawa Saitama, Japan | Complaint file establishment, Specification developer | 3 | April 29, 2005 | 0 | 0 | 0 | api.fda.gov |
| Nihon Kohden Tomioka Corporation | Gunma Tokyo, Japan | Manufacturer | 1 | May 8, 2001 | 0 | 0 | 0 | api.fda.gov |
| Nihon Vinyl Cord Corporation - Kodama Second Factory | Honjo-shi Saitama, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.