SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITOR


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

Correspodent Contact thomas kroenke
Regulation Number 870.1130
Classification Product Code
DXN  
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