AUDICOR SENSOR, MODELS: 2.0, 3.0


Device Classification Name

electrode, electrocardiograph

510(k) Number K080602
Device Name AUDICOR SENSOR, MODELS: 2.0, 3.0
Applicant
INOVISE MEDICAL, INC.
10565 sw nimbus ave.
suite 100
portland, 
OR 
97223

Applicant Contact kendra rathkey
Correspondent
INOVISE MEDICAL, INC.
10565 sw nimbus ave.
suite 100
portland, 
OR 
97223

Correspodent Contact kendra rathkey
Regulation Number 870.2360
Classification Product Code
DRX  
Subsequent Product Code
DQD  
Date Received 03/03/2008
Decision Date 09/25/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No