PC ECG 1200W SYSTEM


Device Classification Name

monitor,physiological,patient(without arrhythmia detection or alarms)

510(k) Number K080141
Device Name PC ECG 1200W SYSTEM
Applicant
NORAV MEDICAL LTD.
industrial park 13
m.p. misgav
mitzpe aviv, 

IL

20187

Applicant Contact benny arazy
Correspondent
NORAV MEDICAL LTD.
industrial park 13
m.p. misgav
mitzpe aviv, 

IL

20187

Correspodent Contact benny arazy
Regulation Number 870.2300
Classification Product Code
MWI  
Date Received 01/22/2008
Decision Date 04/25/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No