The following data is part of a premarket notification filed by Advanced Instrumentations, Inc. with the FDA for Dus-3000/dus-3000plus Digital Ultrasonic Diagnostic Imaging System.
| Device ID | K112022 |
| 510k Number | K112022 |
| Device Name: | DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | ADVANCED INSTRUMENTATIONS, INC. 601 WEST 20 ST Hialeah, FL 33010 |
| Contact | Jorge Millan |
| Correspondent | Jorge Millan ADVANCED INSTRUMENTATIONS, INC. 601 WEST 20 ST Hialeah, FL 33010 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-15 |
| Decision Date | 2011-09-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B510DUS30001 | K112022 | 000 |