Device Classification Name |
Cerebral Oximeter
|
510(k) Number |
K182242 |
Device Name |
VO200 – NeurOs Cerebral Oximetry System |
Applicant |
Mespere LifeSciences Inc. |
180 Frobisher Drive, Suite 1C |
Waterloo,
CA
N2V 2A2
|
|
Applicant Contact |
Rebecca S. Li |
Correspondent |
Mespere LifeSciences Inc. |
180 Frobisher Drive, Suite 1C |
Waterloo,
CA
N2V 2A2
|
|
Correspondent Contact |
Rebecca S. Li |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 08/20/2018 |
Decision Date | 12/26/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|