CARDIOMEM


Device Classification Name

electrocardiograph,ambulatory(without analysis)

510(k) Number K122272
Device Name CARDIOMEM
Applicant
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG
55 northern blvd
suite 200
great neck, 
NY 
11021

Applicant Contact susan d goldstein-falk
Correspondent
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG
55 northern blvd
suite 200
great neck, 
NY 
11021

Correspodent Contact susan d goldstein-falk
Regulation Number 870.2800
Classification Product Code
MWJ  
Date Received 07/30/2012
Decision Date 03/28/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No