AMERITEK SURE-POINT TRACKER SYSTEM


Device Classification Name

transducer, ultrasonic, diagnostic

510(k) Number K030518
Device Name AMERITEK SURE-POINT TRACKER SYSTEM
Applicant
AMERTEK MEDICAL, INC.
2655 n. ocean dr. #405
singer island, 
FL 
33404

Applicant Contact greg wiita
Correspondent
AMERTEK MEDICAL, INC.
2655 n. ocean dr. #405
singer island, 
FL 
33404

Correspodent Contact greg wiita
Regulation Number 892.1570
Classification Product Code
ITX  
Date Received 02/19/2003
Decision Date 05/20/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No