The following data is part of a premarket notification filed by Crystalline Medical with the FDA for Vu-path Ultrasound System.
| Device ID | K203657 |
| 510k Number | K203657 |
| Device Name: | Vu-Path Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Crystalline Medical 48890 Milmont Drive Suite 106D Fremont, CA 94538 |
| Contact | Ivan Ma |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| 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 | Yes |
| Combination Product | No |
| Date Received | 2020-12-15 |
| Decision Date | 2021-06-25 |