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 | K091680 |
| 510k Number | K091680 |
| Device Name: | DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | EDAN INSTRUMENTS, INC. 1 ODELL PLAZA Yonkers, NY 10701 |
| Contact | William Stern |
| 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 | 2009-06-10 |
| Decision Date | 2009-06-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815871020435 | K091680 | 000 |