ECARD AND CCARD


Device Classification Name

transmitters and receivers, electrocardiograph, telephone

510(k) Number K081471
Device Name ECARD AND CCARD
Applicant
IRHYTHM TECHNOLOGIES, INC.
650 townsend street
suite 380
san francisco, 
CA 
94103

Applicant Contact william h righter
Regulation Number 870.2920
Classification Product Code
DXH  
Date Received 05/27/2008
Decision Date 06/24/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

statement

statement

Type Traditional
Reviewed by Third Party Yes

Combination Product

No