Device Classification Name |
system, imaging, optical coherence tomography (oct)
|
510(k) Number |
K190404 |
Device Name |
OTIS Optical Coherence Tomography SYstem |
Applicant |
Perimeter Medical Imaging, Inc. |
1 Yonge Street, Suite 201 |
Toronto,
CA
M5E !E6
|
|
Applicant Contact |
Elizabeth Munro |
Correspondent |
Domecus Consulting Services LLC |
1171 Barroilhet Drive |
California,
CA
94010
|
|
Correspondent Contact |
Cindy Domecus |
Regulation Number | 892.1560
|
Classification Product Code |
|
Date Received | 02/19/2019 |
Decision Date | 03/26/2019 |
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
|
|
|