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
|
|
Correspondent Contact |
GREG WIITA |
Regulation Number | 892.1570
|
Classification Product Code |
|
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
|
|
|