NH-301 AMBULATORY ECG ANALYSIS SOFTWARE


Device Classification Name

electrocardiograph, ambulatory, with analysis algorithm

510(k) Number K111487
Device Name NH-301 AMBULATORY ECG ANALYSIS SOFTWARE
Applicant
NORAV MEDICAL CORP.
industrial park 13,
m.p. misgav
mitzpe aviv, 

IL

20187

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

IL

20187

Correspodent Contact benny arazy
Regulation Number 870.2800
Classification Product Code
MLO  
Date Received 05/31/2011
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