Device Classification Name |
system, measurement, blood-pressure, non-invasive
|
510(k) Number |
K060820 |
Device Name |
CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060 |
Applicant |
SUNTECH MEDICAL, INC. |
507 AIRPORT BOULEVARD |
SUITE 117 |
MORRISVILLE,
NC
27560
|
|
Applicant Contact |
DAVID GALLICK |
Correspondent |
SUNTECH MEDICAL, INC. |
507 AIRPORT BOULEVARD |
SUITE 117 |
MORRISVILLE,
NC
27560
|
|
Correspondent Contact |
DAVID GALLICK |
Regulation Number | 870.1130
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/27/2006 |
Decision Date | 06/07/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|