EVERON CENTRAL DISPLAY STATION (CDS)


Device Classification Name

system,network and communication,physiological monitors

510(k) Number K110521
Device Name EVERON CENTRAL DISPLAY STATION (CDS)
Applicant
EARLYSENSE LTD.
tzvi 12
ramat-gan, 

IL

52504

Applicant Contact dalia argaman
Correspondent
EARLYSENSE LTD.
tzvi 12
ramat-gan, 

IL

52504

Correspodent Contact dalia argaman
Regulation Number 870.2300
Classification Product Code
MSX  
Date Received 02/23/2011
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