RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT
FDA 510(k) clearance K964338 · decided 1997-01-09
Clearance details
- K-number
- K964338
- Device name
- RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT
- Applicant
- Rudolf Riester GmbH & Co. KG
- Decision
- Substantially Equivalent
- Date received
- 1996-10-31
- Decision date
- 1997-01-09
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- HKM
- Device class
- 1
- Regulation number
- 886.1780
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- D-72417 Jungingen, DE
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Rudolf Riester GmbH & Co. KG
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| STREAK RETINOSCOPE RX-3 (K950791) | Neitz Instruments Company, Ltd. | 1995-03-28 |
| 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.