Neitz Instruments Company, Ltd.
Chiyoda-Ku, JP
NEITZ INSTRUMENTS COMPANY, LTD. appears in FDA device records in Chiyoda-Ku, JP. FDA records list 24 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 24 510(k) clearances for Neitz Instruments Company, Ltd. between 1994 and 1997. The busiest year on record is 1995, with 14. The most recent is 1997, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 9 |
| 1995 | 14 |
| 1997 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K972440 | CATARACTSCREENER CT - S | HKI | Substantially Equivalent | |
| K951341 | NEITZ SLIT LAMP SL-H2 | HJO | Substantially Equivalent | |
| K951337 | FIBER HEAD LIGHT FH-300 | HPQ | Substantially Equivalent | |
| K950788 | OTOSCOPE A-34 | ERA | Substantially Equivalent | |
| K951340 | NEITZ SLIT LAMP SL-H1 | HJO | Substantially Equivalent | |
| K951338 | INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TV | HLI | Substantially Equivalent | |
| K950797 | HALOGEN OPHTHALMO-OTOSCOPE SET BX A - 134 | HLJ | Substantially Equivalent | |
| K950795 | STREAK RETINOSCOPE RX-RP | HKM | Substantially Equivalent | |
| K950794 | STREAK RETINOSCOPE RX-RC | HKM | Substantially Equivalent | |
| K950793 | SPOT RETINOSCOPE RX-3SP | HKM | Substantially Equivalent | |
| K950792 | STREAK RETINOSCOPE RX-3A | HKM | Substantially Equivalent | |
| K950791 | STREAK RETINOSCOPE RX-3 | HKM | Substantially Equivalent | |
| K950789 | STREAK RETINOSCOPE RX-1 | HKL | Substantially Equivalent | |
| K950796 | HALOGEN DIAGNOSTIC SET BX A - 12345 | HLJ | Substantially Equivalent | |
| K950790 | STREAK RETINOSCOPE RX-2 | HKL | Substantially Equivalent | |
| K942721 | NEITZ HALOGEN OPHTHALMOSCOPE BXA-13 | HLJ | Substantially Equivalent | |
| K942720 | NEITZ HALOGEN OPHTHALMOSCOPE BXA-12 | HLI | Substantially Equivalent | |
| K942719 | NEITZ HALOGEN POCKET OPHTHALMOSCOPE A-JR | HLJ | Substantially Equivalent | |
| K942717 | NEITZ HALOGEN OPHTHALMOSCOPE BXA-13A | HLJ | Substantially Equivalent | |
| K942715 | NEITZ HALOGEN OPHTHALMOSCOPE BXA-RC | HLI | Substantially Equivalent | |
| K942714 | NEITZ HALOGEN OPHTHALMOSCOPE BXA-RP | HLI | Substantially Equivalent | |
| K942713 | NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-H | HLI | Substantially Equivalent | |
| K942712 | NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-A | HLI | Substantially Equivalent | |
| K942711 | NEITZ HALOGEN OPHTHALMOSCOPE BXA-123 | HLI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8043512 | 3002807701 | NEITZ INSTRUMENTS COMPANY, LTD. | 4F ICHIBANCHO COURT, CHIYODA-KU Tokyo 102-0082 JP | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HIWAnomaloscope
- HJOBiomicroscope, Slit-Lamp, Ac-Powered
- HKICamera, Ophthalmic, Ac-Powered
- FMADepressor, Tongue, Non-Surgical
- HLFDevice, Measuring, Lens Radius, Ophthalmic
- HPQHeadlamp, Operating, Ac-Powered
- HPPHeadlamp, Operating, Battery-Operated
- HJLLens, Condensing, Diagnostic
- KYTLight, Examination, Medical, Battery Powered
- HJHLoupe, Binocular, Low Power
- HLIOphthalmoscope, Ac-Powered
- HLJOphthalmoscope, Battery-Powered
- ERAOtoscope
- HKLRetinoscope, Ac-Powered
- HKMRetinoscope, Battery-Powered
- HJNTransilluminator, Battery-Powered
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain