510(k) K800238
- Device
- Moire Fringe Visometer After Lotmar
- Applicant
- HAGG-STREIT SERVICE, INC.
- 510(k) number
- K800238
- Product code
- HKL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-03-10
- Date received
- 1980-02-05
- Regulation
- 886.1780
- Classification name
- Retinoscope, Ac-Powered
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1000391004
- 3010227033
- 3013436538
- 3011898560
- 3003951061
- 3006252153
- 3004765453
- 2521877
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HKL#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K001111 | PANORET, MODEL 1000A | Cmt Medical Technologies, Ltd. | 2000-07-07 |
| K950789 | STREAK RETINOSCOPE RX-1 | Neitz Instruments Company, Ltd. | 1995-03-28 |
| K950790 | STREAK RETINOSCOPE RX-2 | Neitz Instruments Company, Ltd. | 1995-03-22 |
| K893171 | VISTA STREAK RETINOSCOPE (AC-POWERED) | Keeler Instruments, Inc. | 1989-09-21 |
| K812764 | KOI BLUE FIELD ENTOPTOSCOPE | Koi, Inc. | 1981-12-02 |