The following data is part of a premarket notification filed by Diagnostic Ultrasound Corp. with the FDA for Ud 2000 Video Option.
| Device ID | K915342 |
| 510k Number | K915342 |
| Device Name: | UD 2000 VIDEO OPTION |
| Classification | System, Image Processing, Radiological |
| Applicant | DIAGNOSTIC ULTRASOUND CORP. P.O. BOX 0789 Kirkland, WA 98083 -0789 |
| Contact | Gerald Mcmorrow |
| Correspondent | Gerald Mcmorrow DIAGNOSTIC ULTRASOUND CORP. P.O. BOX 0789 Kirkland, WA 98083 -0789 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-26 |
| Decision Date | 1992-06-10 |