Device Classification Name |
Camera, Ophthalmic, Ac-Powered
|
510(k) Number |
K040325 |
Device Name |
PANORET, MODEL PNM 60 |
Applicant |
MEDIBELL MEDICAL VISION TECHNOLOGIES LTD. |
MATAM HIGHT TECHNOLOGIES CTR |
HAIFA,
IL
31905
|
|
Applicant Contact |
DAN LAOR |
Correspondent |
MEDIBELL MEDICAL VISION TECHNOLOGIES LTD. |
MATAM HIGHT TECHNOLOGIES CTR |
HAIFA,
IL
31905
|
|
Correspondent Contact |
DAN LAOR |
Regulation Number | 886.1120
|
Classification Product Code |
|
Date Received | 02/10/2004 |
Decision Date | 03/08/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|