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 | K110999 |
| 510k Number | K110999 |
| Device Name: | DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | EDAN INSTRUMENTS, INC. 4/F, NEW ENERGY BLDG., 2009 NANYOU ROAD Nanshan, Guangdong, CN 518054 |
| Contact | Randy Jiang |
| Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-04-11 |
| Decision Date | 2011-04-26 |
| Summary: | summary |