The following data is part of a premarket notification filed by Amertek Medical, Inc. with the FDA for Ameritek Sure-point Tracker System.
| Device ID | K030518 |
| 510k Number | K030518 |
| Device Name: | AMERITEK SURE-POINT TRACKER SYSTEM |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | AMERTEK MEDICAL, INC. 2655 N. OCEAN DR. #405 Singer Island, FL 33404 |
| Contact | Greg Wiita |
| Correspondent | Greg Wiita AMERTEK MEDICAL, INC. 2655 N. OCEAN DR. #405 Singer Island, FL 33404 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-19 |
| Decision Date | 2003-05-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00801741079177 | K030518 | 000 |
| 00801741078897 | K030518 | 000 |
| 00801741079054 | K030518 | 000 |
| 00801741079061 | K030518 | 000 |
| 00801741079092 | K030518 | 000 |
| 00801741079108 | K030518 | 000 |
| 00801741079122 | K030518 | 000 |
| 00801741079139 | K030518 | 000 |
| 00801741079146 | K030518 | 000 |
| 00801741078880 | K030518 | 000 |