AUDICOR COR SENSOR (AND ACCESSORY ADAPTOR)


Device Classification Name

electrode, electrocardiograph

510(k) Number K030316
Device Name AUDICOR COR SENSOR (AND ACCESSORY ADAPTOR)
Original Applicant
INOVISE MEDICAL, INC.
1025 industrial pkwy.
suite c
newberg, 
OR 
97132

Original Contact kendra rathkey
Regulation Number 870.2360
Classification Product Code
DRX  
Subsequent Product Code
DQD  
Date Received 01/30/2003
Decision Date 08/07/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No