SPACELABS SMART DISCLOSURE SYSTEM


Device Classification Name

computer, diagnostic, programmable

510(k) Number K110779
Device Name SPACELABS SMART DISCLOSURE SYSTEM
Applicant
SPACELABS HEALTHCARE
p.o. box 3018
nederland, 
CO 
80466

Applicant Contact thomas kroenke
Correspondent
SPACELABS HEALTHCARE
p.o. box 3018
nederland, 
CO 
80466

Correspodent Contact thomas kroenke
Regulation Number 870.1425
Classification Product Code
DQK  
Date Received 03/21/2011
Decision Date 04/19/2011
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