PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS)


Device Classification Name

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

510(k) Number K110463
Device Name PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS)
Applicant
NORAV MEDICAL LTD.
industrial park 13
m.p. misgav
mitzpe aviv, 

IL

20187

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

IL

20187

Correspodent Contact benry arazy
Regulation Number 870.2300
Classification Product Code
MWI  
Date Received 02/17/2011
Decision Date 11/10/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No