The following data is part of a premarket notification filed by Advanced Instrumentations, Inc. with the FDA for Diagnostic Ultrasound System.
| Device ID | K132059 |
| 510k Number | K132059 |
| Device Name: | DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | ADVANCED INSTRUMENTATIONS, INC. 601 WEST 20TH STREET Hialeah, FL 33010 |
| Contact | Jorge Millan |
| Correspondent | Jorge Millan ADVANCED INSTRUMENTATIONS, INC. 601 WEST 20TH STREET Hialeah, FL 33010 |
| 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 | 2013-07-03 |
| Decision Date | 2013-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B510DUS5000A1 | K132059 | 000 |