The following data is part of a premarket notification filed by Tetra Corp. with the FDA for Tetrad 2300 E/u Ultrasoung Imaging System.
| Device ID | K946277 |
| 510k Number | K946277 |
| Device Name: | TETRAD 2300 E/U ULTRASOUNG IMAGING SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | TETRA CORP. 357 INVERNESS DRIVE SOUTH UNIT A Englewood, CO 80112 -5816 |
| Contact | Dennis R Dietz |
| Correspondent | Dennis R Dietz TETRA CORP. 357 INVERNESS DRIVE SOUTH UNIT A Englewood, CO 80112 -5816 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-27 |
| Decision Date | 1996-03-15 |