The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Digital Ultrasonic Diagnostic Imaging System.
| Device ID | K131830 |
| 510k Number | K131830 |
| Device Name: | DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | EDAN INSTRUMENTS, INC. EQUIPMENTS PARK, NANHAI RD 1019 NO. SHEKOU NANSHAN Shenzhen, CN 518067 |
| Contact | Cherry Sun |
| Correspondent | Cherry Sun EDAN INSTRUMENTS, INC. EQUIPMENTS PARK, NANHAI RD 1019 NO. SHEKOU NANSHAN Shenzhen, CN 518067 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-20 |
| Decision Date | 2013-09-17 |
| Summary: | summary |