Device Classification Name |
System, Imaging, Optical Coherence Tomography (Oct)
|
510(k) Number |
K093520 |
Device Name |
VIVOSIGHT TOPICAL OCT SYSTEM |
Applicant |
MICHELSON DIAGNOSTICS LTD. |
11A GRAYS FARM PRODUCTION VILL |
GRAYS FARM ROAD |
ORPINGTON, KENT,
GB
BR5 3BD
|
|
Applicant Contact |
MARTIN JOHNS |
Correspondent |
MICHELSON DIAGNOSTICS LTD. |
11A GRAYS FARM PRODUCTION VILL |
GRAYS FARM ROAD |
ORPINGTON, KENT,
GB
BR5 3BD
|
|
Correspondent Contact |
MARTIN JOHNS |
Regulation Number | 892.1560
|
Classification Product Code |
|
Date Received | 11/13/2009 |
Decision Date | 01/05/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|