Device Classification Name |
retinoscope, ac-powered
|
510(k) Number |
K001111 |
Device Name |
PANORET, MODEL 1000A |
Applicant |
CMT MEDICAL TECHNOLOGIES, LTD. |
MATAM HIGH TECHNOLOGY CENTER |
HAIFA,
IL
31905
|
|
Applicant Contact |
ILAN SHARON |
Correspondent |
CMT MEDICAL TECHNOLOGIES, LTD. |
MATAM HIGH TECHNOLOGY CENTER |
HAIFA,
IL
31905
|
|
Correspondent Contact |
ILAN SHARON |
Regulation Number | 886.1780
|
Classification Product Code |
|
Date Received | 04/06/2000 |
Decision Date | 07/07/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|