Ameritek Sure-Point Tracker System

FDA 510(k) K030518 · Amertek Medical, Inc.

Substantially Equivalent

510(k) numberK030518

Submission

Device name
Ameritek Sure-Point Tracker System
Applicant
Amertek Medical, Inc.
Singer Island, FL, US
Received
February 19, 2003
Decision date
May 20, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
ITX – Transducer, Ultrasonic, Diagnostic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1570
Specialty
Radiology

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Questions and answers

When was Ameritek Sure-Point Tracker System cleared by the FDA?

Ameritek Sure-Point Tracker System (K030518) received a 510(k) decision of Substantially Equivalent on May 20, 2003, 90 days after the submission was received.

What is the product code of K030518?

The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.