CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1005


Device Classification Name

detector and alarm, arrhythmia

510(k) Number K072558
Device Name CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1005
Applicant
CARDIONET, INC
1010 2nd ave., suite 700
san diego, 
CA 
92101

Applicant Contact jack gaikwad
Correspondent
CARDIONET, INC
1010 2nd ave., suite 700
san diego, 
CA 
92101

Correspodent Contact jack gaikwad
Regulation Number 870.1025
Classification Product Code
DSI  
Subsequent Product Code
MLO  
Date Received 09/11/2007
Decision Date 12/05/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No