Device Classification Name |
Ophthalmoscope, Ac-Powered
|
510(k) Number |
K914484 |
Device Name |
LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPE |
Applicant |
HGM MEDICAL LASER SYSTEMS, INC. |
3959 WEST 1820 SOUTH |
SALT LAKE CITY,
UT
84104
|
|
Applicant Contact |
GREGORY R MCARTHUR |
Correspondent |
HGM MEDICAL LASER SYSTEMS, INC. |
3959 WEST 1820 SOUTH |
SALT LAKE CITY,
UT
84104
|
|
Correspondent Contact |
GREGORY R MCARTHUR |
Regulation Number | 886.1570
|
Classification Product Code |
|
Date Received | 10/08/1991 |
Decision Date | 01/06/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|