ECG CHECK


Device Classification Name

transmitters and receivers, electrocardiograph, telephone

510(k) Number K122184
Device Name ECG CHECK
Applicant
CARDIAC DESIGNS, LLC
3293 niblick drive
park city, 
UT 
84098

Applicant Contact karim marrouche
Correspondent
CARDIAC DESIGNS, LLC
3293 niblick drive
park city, 
UT 
84098

Correspodent Contact karim marrouche
Regulation Number 870.2920
Classification Product Code
DXH  
Date Received 07/23/2012
Decision Date 02/14/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No