Device Classification Name |
Tomography, Optical Coherence
|
510(k) Number |
K121993 |
Device Name |
SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCT |
Applicant |
HEIDELBERG ENGINEERING GMBH |
2995 STEVEN MARTIN DR. |
FAIRFAX,
VA
22031
|
|
Applicant Contact |
DIANE HORWITZ, PH.D. |
Correspondent |
HEIDELBERG ENGINEERING GMBH |
2995 STEVEN MARTIN DR. |
FAIRFAX,
VA
22031
|
|
Correspondent Contact |
DIANE HORWITZ, PH.D. |
Regulation Number | 886.1570
|
Classification Product Code |
|
Date Received | 07/06/2012 |
Decision Date | 10/25/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|