510(k) K001111
- Device
- PANORET, MODEL 1000A
- Applicant
- CMT MEDICAL TECHNOLOGIES, LTD.
- 510(k) number
- K001111
- Product code
- HKL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-07-07
- Date received
- 2000-04-06
- Regulation
- 886.1780
- Classification name
- Retinoscope, Ac-powered
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ILAN SHARON
- Address
- Matam High Technology Center Haifa IL 31905 31905
FDA Registration Numbers#
- 3004765453
- 3010227033
- 3006252153
- 1000391004
- 3013436538
- 2521877
- 3011898560
- 3003951061
Source Documents#
Other 510(k) Records For Product Code HKL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K800238 | MOIRE FRINGE VISOMETER AFTER LOTMAR | Hagg-Streit Service, Inc. | 1980-03-10 |
Legacy Summary#
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FDA Review#
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