EARLYSENSE CENTRAL DISPLAY SYSTEM


Device Classification Name

system,network and communication,physiological monitors

510(k) Number K121885
Device Name EARLYSENSE CENTRAL DISPLAY SYSTEM
Applicant
EARLYSENSE LTD.
12 tzvi st
ramat-gan, 

IL

52504

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

IL

52504

Correspodent Contact dalia argaman
Regulation Number 870.2300
Classification Product Code
MSX  
Date Received 06/28/2012
Decision Date 09/10/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No