Device Classification Name |
camera, ophthalmic, ac-powered
|
510(k) Number |
K082196 |
Device Name |
STATIC VESSEL ANALYZER |
Applicant |
IMEDOS GMBH |
317 SHORE BREEZE LANE |
LEAGUE CITY,
TX
77573
|
|
Applicant Contact |
HANS STROMEYER |
Correspondent |
IMEDOS GMBH |
317 SHORE BREEZE LANE |
LEAGUE CITY,
TX
77573
|
|
Correspondent Contact |
HANS STROMEYER |
Regulation Number | 886.1120
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/04/2008 |
Decision Date | 06/16/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|