VISTA STREAK RETINOSCOPE (AC-POWERED)
FDA 510(k) clearance K893171 · decided 1989-09-21
Clearance details
- K-number
- K893171
- Device name
- VISTA STREAK RETINOSCOPE (AC-POWERED)
- Applicant
- Keeler Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-04-25
- Decision date
- 1989-09-21
- Days to decision
- 149 days
- Clearance type
- Traditional
- Product code
- HKL
- Device class
- 2
- Regulation number
- 886.1780
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Broomall, PA, US
- 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 |
|---|---|---|
| PANORET, MODEL 1000A (K001111) | Cmt Medical Technologies, Ltd. | 2000-07-07 |
| STREAK RETINOSCOPE RX-1 (K950789) | Neitz Instruments Company, Ltd. | 1995-03-28 |
| STREAK RETINOSCOPE RX-2 (K950790) | Neitz Instruments Company, Ltd. | 1995-03-22 |
| KOI BLUE FIELD ENTOPTOSCOPE (K812764) | Koi, Inc. | 1981-12-02 |
| MOIRE FRINGE VISOMETER AFTER LOTMAR (K800238) | Hagg-Streit Service, Inc. | 1980-03-10 |
Recalls involving this device
No recalls on record reference this clearance.