Data / Medical devices / Japan / H. Ogino & Co., Ltd.
H. Ogino & Co., Ltd.: FDA-registered device maker in Yokohama Kanagawa, Japan, 1 510(k) clearance
H. Ogino & Co., Ltd. is registered with the FDA (registration 5470) in Yokohama Kanagawa, Japan. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 6, 1993. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 5470
- Address
- Yamashitacho 75, Nakaku, Yokohama Kanagawa, Japan, 2310023
- Owner or operator
- H. Ogino & Co., Ltd. (10051654)
- Roles
- Exporter to the US
- First device listed
- April 17, 2016
- Registered through
- 2026
- Brand names listed
- Chart, visual acuity, Exophthalmometer, Frame, trial, ophthalmic, Instrument, measuring, lens, ac-powered, Refractor, manual, non-powered, including phoropter, Set, lens, trial, ophthalmic
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Chart, Visual Acuity | HOX | 1 | Exporter to the US | accessdata.fda.gov |
| Exophthalmometer | HLS | 1 | Exporter to the US | accessdata.fda.gov |
| Frame, Trial, Ophthalmic | HPA | 1 | Exporter to the US | accessdata.fda.gov |
| Instrument, Measuring, Lens, Ac-Powered | HLM | 1 | Exporter to the US | accessdata.fda.gov |
| Refractor, Manual, Non-Powered, Including Phoropter | HKN | 1 | Exporter to the US | accessdata.fda.gov |
| Set, Lens, Trial, Ophthalmic | HPC | 1 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| July 6, 1993 | K930446 | MARCO TRIAL SETS | HPC | Substantially Equivalent | Marco Ophthalmic, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Set, Lens, Trial, Ophthalmic
- All makers of Refractor, Manual, Non-Powered, Including Phoropter
- All makers of Exophthalmometer
- All makers of Frame, Trial, Ophthalmic
- All makers of Instrument, Measuring, Lens, Ac-Powered
- All makers of Chart, Visual Acuity
Updated July 6, 1993. 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.