The following data is part of a premarket notification filed by 3g Ultrasound, Inc. with the FDA for Sonalis, Model 2000.
| Device ID | K043189 |
| 510k Number | K043189 |
| Device Name: | SONALIS, MODEL 2000 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | 3G ULTRASOUND, INC. 12672 CORAL LAKES DRIVE Boynton Beach, FL 33437 |
| Contact | Paul Schneider |
| Correspondent | Paul Schneider 3G ULTRASOUND, INC. 12672 CORAL LAKES DRIVE Boynton Beach, FL 33437 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-17 |
| Decision Date | 2005-02-09 |
| Summary: | summary |