The following data is part of a premarket notification filed by Tetrad Corp. with the FDA for Sonata 3-d Imaging Accessory, Model 3ds.
| Device ID | K042620 |
| 510k Number | K042620 |
| Device Name: | SONATA 3-D IMAGING ACCESSORY, MODEL 3DS |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| 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 | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-27 |
| Decision Date | 2004-12-23 |
| Summary: | summary |