The following data is part of a premarket notification filed by Tetrad Corp. with the FDA for Tetrad Model Tc-ec7-acp, -l5-, -l7-, -v4-acp Transducers.
| Device ID | K013849 |
| 510k Number | K013849 |
| Device Name: | TETRAD MODEL TC-EC7-ACP, -L5-, -L7-, -V4-ACP TRANSDUCERS |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | TETRAD CORP. 357 INVERNESS DR. SOUTH, SUITE A Englewood, CO 80112 |
| Contact | Charles F Hottinger |
| Correspondent | Mark Job TUV PRODUCT SERVICE, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-11-20 |
| Decision Date | 2001-12-03 |
| Summary: | summary |