Device Classification Name |
System, Digital Image Communications, Radiological
|
510(k) Number |
K941224 |
Device Name |
LENZAR REMOTE ACQUISITION SYSTEM |
Applicant |
LENZAR ELECTROOPTICS, INC. |
1006 W. 15TH ST. |
RIVIERA BEACH,
FL
33404
|
|
Applicant Contact |
HAROLD BEARDEN |
Correspondent |
LENZAR ELECTROOPTICS, INC. |
1006 W. 15TH ST. |
RIVIERA BEACH,
FL
33404
|
|
Correspondent Contact |
HAROLD BEARDEN |
Regulation Number | 892.2020
|
Classification Product Code |
|
Date Received | 03/14/1994 |
Decision Date | 12/09/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|