STREAK RETINOSCOPE RX-3
FDA 510(k) clearance K950791 · decided 1995-03-28
Clearance details
- K-number
- K950791
- Device name
- STREAK RETINOSCOPE RX-3
- Applicant
- Neitz Instruments Company, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1995-02-21
- Decision date
- 1995-03-28
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- HKM
- Device class
- 1
- Regulation number
- 886.1780
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Tokyo, JP
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT (K964338) | Rudolf Riester GmbH & Co. KG | 1997-01-09 |
| STREAK RETINOSCOPE RX-RP (K950795) | Neitz Instruments Company, Ltd. | 1995-03-28 |
| SPOT RETINOSCOPE RX-3SP (K950793) | Neitz Instruments Company, Ltd. | 1995-03-28 |
| STREAK RETINOSCOPE RX-RC (K950794) | Neitz Instruments Company, Ltd. | 1995-03-28 |
| STREAK RETINOSCOPE RX-3A (K950792) | Neitz Instruments Company, Ltd. | 1995-03-28 |
| GENERATED RETINAL REFLEX IMAGERY SYS (K840840) | Electro Optical Instruments | 1984-07-12 |
Recalls involving this device
No recalls on record reference this clearance.