The following data is part of a premarket notification filed by Qisda Corporation with the FDA for Up600 Diagnostic Doppler Ultrasound System.
| Device ID | K132690 |
| 510k Number | K132690 |
| Device Name: | UP600 DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | QISDA CORPORATION 7263 CRONIN CIRCLE Dublin, CA 94568 |
| Contact | Bob Leiker |
| Correspondent | Bob Leiker QISDA CORPORATION 7263 CRONIN CIRCLE Dublin, CA 94568 |
| 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 | 2013-08-28 |
| Decision Date | 2014-02-25 |
| Summary: | summary |