The following data is part of a premarket notification filed by Tetra Corp. with the FDA for New Ultrasound Imaging System & Transducers.
| Device ID | K924204 |
| 510k Number | K924204 |
| Device Name: | NEW ULTRASOUND IMAGING SYSTEM & TRANSDUCERS |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | TETRA CORP. C/0 WILLIAM E. MCKAY, CONSULT 6110 BOLLINGER ROAD San Jose, CA 95129 |
| Contact | William E Mckay |
| Correspondent | William E Mckay TETRA CORP. C/0 WILLIAM E. MCKAY, CONSULT 6110 BOLLINGER ROAD San Jose, CA 95129 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-20 |
| Decision Date | 1993-06-07 |