The following data is part of a premarket notification filed by Linkquest Inc. with the FDA for Linkquest Diagnostic Ultrasound System Model Sq860.
| Device ID | K172059 |
| 510k Number | K172059 |
| Device Name: | LinkQuest Diagnostic Ultrasound System Model SQ860 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | LinkQuest Inc. 6749 Top Gun Street #100 San Diego, CA 92121 |
| Contact | Xiaolong Yu |
| Correspondent | Xiaolong Yu LinkQuest Inc. 6749 Top Gun Street #100 San Diego, CA 92121 |
| 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 | 2017-07-07 |
| Decision Date | 2017-10-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860000784856 | K172059 | 000 |
| 00860000784849 | K172059 | 000 |
| 00860000784832 | K172059 | 000 |
| 00860000784825 | K172059 | 000 |
| 00860000784818 | K172059 | 000 |
| 00860000784801 | K172059 | 000 |