Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
|
510(k) Number |
K011058 |
Device Name |
TELEPRESS III BLOOD PRESSURE MONITOR, MODEL TPIII |
Applicant |
MERIDIAN MEDICAL TECHNOLOGIES LTD. |
207 AIRPORT RD., WEST |
BELFAST,
IE
BT3 9ED
|
|
Applicant Contact |
RHONA LOVE |
Correspondent |
MERIDIAN MEDICAL TECHNOLOGIES LTD. |
207 AIRPORT RD., WEST |
BELFAST,
IE
BT3 9ED
|
|
Correspondent Contact |
RHONA LOVE |
Regulation Number | 870.1130
|
Classification Product Code |
|
Date Received | 04/06/2001 |
Decision Date | 10/23/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|