HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME


Device Classification Name

electrocardiograph

510(k) Number K111159
Device Name HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME
Applicant
CARDIO COMM SOLUTIONS, INC.
962 allegro lane
apollo beach, 
FL 
33572

Applicant Contact jonathan ward
Correspondent
CARDIO COMM SOLUTIONS, INC.
962 allegro lane
apollo beach, 
FL 
33572

Correspodent Contact jonathan ward
Regulation Number 870.2340
Classification Product Code
DPS  
Date Received 04/25/2011
Decision Date 12/22/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No