The following data is part of a premarket notification filed by Dolphin Medical Imaging, Llc with the FDA for Dolphin Medical Imaging Usb Ultrasound System.
| Device ID | K192573 |
| 510k Number | K192573 |
| Device Name: | Dolphin Medical Imaging USB Ultrasound System |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | Dolphin Medical Imaging, LLC 161 Dawn River Way Folsom, CA 95630 |
| Contact | Brian S. Heaney |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2019-09-18 |
| Decision Date | 2019-11-19 |
| Summary: | summary |