SPACELABS PATHFINDER SL HOLTER ANALYZER


Device Classification Name

computer, diagnostic, programmable

510(k) Number K110001
Device Name SPACELABS PATHFINDER SL HOLTER ANALYZER
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 870.1425
Classification Product Code
DQK  
Subsequent Product Code
MNR  
Date Received 01/03/2011
Decision Date 06/14/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls