MOIRE FRINGE VISOMETER AFTER LOTMAR
FDA 510(k) clearance K800238 · decided 1980-03-10
Clearance details
- K-number
- K800238
- Device name
- MOIRE FRINGE VISOMETER AFTER LOTMAR
- Applicant
- Hagg-Streit Service, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-02-05
- Decision date
- 1980-03-10
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- HKL
- Device class
- 2
- Regulation number
- 886.1780
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Mchenry, IL, 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 |
| VISTA STREAK RETINOSCOPE (AC-POWERED) (K893171) | Keeler Instruments, Inc. | 1989-09-21 |
| KOI BLUE FIELD ENTOPTOSCOPE (K812764) | Koi, Inc. | 1981-12-02 |
Recalls involving this device
No recalls on record reference this clearance.