Device Classification Name |
system, measurement, blood-pressure, non-invasive
|
510(k) Number |
K103732 |
Device Name |
SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITOR |
Applicant |
SPACELABS HEALTHCARE LTD. |
PO BOX 3018 |
NEDERLAND,
CO
80466
|
|
Applicant Contact |
THOMAS KROENKE |
Correspondent |
SPACELABS HEALTHCARE LTD. |
PO BOX 3018 |
NEDERLAND,
CO
80466
|
|
Correspondent Contact |
THOMAS KROENKE |
Regulation Number | 870.1130
|
Classification Product Code |
|
Date Received | 12/22/2010 |
Decision Date | 02/04/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|