Data / Medical devices / Japan / Neitz Instruments Company, Ltd.
Neitz Instruments Company, Ltd.: FDA-registered device maker in CHIYODA-KU Tokyo, Japan, 5 510(k) clearances
Neitz Instruments Company, Ltd. is registered with the FDA (registration 8043512) in CHIYODA-KU Tokyo, Japan. It lists 12 device types. The FDA files 5 510(k) clearances under its listings, the newest dated August 5, 1994. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8043512
- FEI number
- 3002807701
- Address
- 4F Ichibancho Court 15-21, Ichibancho, CHIYODA-KU Tokyo, Japan, 102-0082
- Owner or operator
- NEITZ INSTRUMENTS CO.LTD. (9002089)
- Roles
- Manufacturer
- First device listed
- May 26, 1994
- Registered through
- 2026
- Brand names listed
- -34FO, A COMPONENT OF HALOGEN DIAGNOSTIC S; BXX-12345; ET BXX-12345, A COMPONENT OF HALOGEN DIAGNOSTIC SET BX-12345FO; BX-134FO, Anomaloscope OT-II, BLS-1, BLS-2, BLS-3, BLD-3, BLP-4, BLP-6, BTL-2S, BTL-2N, BXPlus-13, BXPlus-13A, BXa-13, BXa-13A, BXa-RC, BXa13LED, BXa13ALED, BX?13RXLED, BX?13ARXLED, BX?13RXSPLED, BX?13ARXSPLED and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Anomaloscope | HIW | 1 | Manufacturer | accessdata.fda.gov |
| Depressor, Tongue, Non-Surgical | FMA | 1 | Manufacturer | accessdata.fda.gov |
| Device, Measuring, Lens Radius, Ophthalmic | HLF | 1 | Manufacturer | accessdata.fda.gov |
| Headlamp, Operating, Battery-Operated | HPP | 1 | Manufacturer | accessdata.fda.gov |
| Lens, Condensing, Diagnostic | HJL | 1 | Manufacturer | accessdata.fda.gov |
| Light, Examination, Medical, Battery Powered | KYT | 1 | Manufacturer | accessdata.fda.gov |
| Loupe, Binocular, Low Power | HJH | 1 | Manufacturer | accessdata.fda.gov |
| Ophthalmoscope, Ac-Powered | HLI | 2 | Manufacturer | accessdata.fda.gov |
| Ophthalmoscope, Battery-Powered | HLJ | 2 | Manufacturer | accessdata.fda.gov |
| Otoscope | ERA | 1 | Manufacturer | accessdata.fda.gov |
| Retinoscope, Battery-Powered | HKM | 1 | Manufacturer | accessdata.fda.gov |
| Transilluminator, Battery-Powered | HJN | 1 | Manufacturer | 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 5, 1994 | K942721 | NEITZ HALOGEN OPHTHALMOSCOPE BXA-13 | HLJ | Substantially Equivalent | Neitz Instruments Company, Ltd. | accessdata.fda.gov |
| August 5, 1994 | K942717 | NEITZ HALOGEN OPHTHALMOSCOPE BXA-13A | HLJ | Substantially Equivalent | Neitz Instruments Company, Ltd. | accessdata.fda.gov |
| August 5, 1994 | K942715 | NEITZ HALOGEN OPHTHALMOSCOPE BXA-RC | HLI | Substantially Equivalent | Neitz Instruments Company, Ltd. | accessdata.fda.gov |
| August 5, 1994 | K942713 | NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-H | HLI | Substantially Equivalent | Neitz Instruments Company, Ltd. | accessdata.fda.gov |
| August 5, 1994 | K942712 | NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-A | HLI | Substantially Equivalent | Neitz Instruments Company, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Transilluminator, Battery-Powered
- All makers of Ophthalmoscope, Ac-Powered
- All makers of Depressor, Tongue, Non-Surgical
- All makers of Loupe, Binocular, Low Power
- All makers of Otoscope
- All makers of Lens, Condensing, Diagnostic
Updated August 5, 1994. 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.