Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
|
510(k) Number |
K121266 |
Device Name |
CARDIOSCOPE |
Applicant |
PULSECOR LIMITED |
1468 HARWELL AVE. |
CROFTON,
MD
21114
|
|
Applicant Contact |
E.J. Smith |
Correspondent |
PULSECOR LIMITED |
1468 HARWELL AVE. |
CROFTON,
MD
21114
|
|
Correspondent Contact |
E.J. Smith |
Regulation Number | 870.1130
|
Classification Product Code |
|
Date Received | 04/26/2012 |
Decision Date | 12/11/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|