The following data is part of a premarket notification filed by Tetrad Corp. with the FDA for Tetrad Tc-c3-acp.
| Device ID | K002193 |
| 510k Number | K002193 |
| Device Name: | TETRAD TC-C3-ACP |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | TETRAD CORP. 357 INVERNESS DR. SOUTH, SUITE A Englewood, CO 80112 |
| Contact | Dennis R Dietz |
| Correspondent | Dennis R Dietz TETRAD CORP. 357 INVERNESS DR. SOUTH, SUITE A Englewood, CO 80112 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-20 |
| Decision Date | 2001-05-04 |