HEARTEVENT, MODEL AT


Device Classification Name

transmitters and receivers, electrocardiograph, telephone

510(k) Number K072385
Device Name HEARTEVENT, MODEL AT
Applicant
DIAGNOSTIC DEVICES PTY LTD
suite 405 office tower
westfield eastgardens
eastgardens, 

AU

2036

Applicant Contact harry platt
Correspondent
DIAGNOSTIC DEVICES PTY LTD
suite 405 office tower
westfield eastgardens
eastgardens, 

AU

2036

Correspodent Contact harry platt
Regulation Number 870.2920
Classification Product Code
DXH  
Date Received 08/24/2007
Decision Date 01/11/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No