Device Classification Name |
System, Imaging, Optical Coherence Tomography (Oct)
|
510(k) Number |
K121195 |
Device Name |
NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER |
Applicant |
NINEPOINT MEDICAL, INC |
1171 BARROIHET AVENUE |
HILLSBOROUGH,
CA
94010
|
|
Applicant Contact |
CINDY DOMECUS |
Correspondent |
NINEPOINT MEDICAL, INC |
1171 BARROIHET AVENUE |
HILLSBOROUGH,
CA
94010
|
|
Correspondent Contact |
CINDY DOMECUS |
Regulation Number | 892.1560
|
Classification Product Code |
|
Date Received | 04/19/2012 |
Decision Date | 07/25/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|