Device Classification Name |
Non-Invasive Central Venous Manometer
|
510(k) Number |
K131085 |
Device Name |
CENTRAL VENOUS PRESSURE SYSTEM - MESPERE VENUS 1000 |
Applicant |
MESPERE LIFESCIENCES INC. |
180 FROBISHER DR, UNIT 1C |
WATERLOO, ON,
CA
N2V 2A2
|
|
Applicant Contact |
HELEN TAN |
Correspondent |
MESPERE LIFESCIENCES INC. |
180 FROBISHER DR, UNIT 1C |
WATERLOO, ON,
CA
N2V 2A2
|
|
Correspondent Contact |
HELEN TAN |
Regulation Number | 870.1140
|
Classification Product Code |
|
Date Received | 04/18/2013 |
Decision Date | 08/22/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|