The following data is part of a premarket notification filed by Diagnostic Ultrasound Corp. with the FDA for Diagnostic Ultrasound Versadopp 1000.
| Device ID | K904792 |
| 510k Number | K904792 |
| Device Name: | DIAGNOSTIC ULTRASOUND VERSADOPP 1000 |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | DIAGNOSTIC ULTRASOUND CORP. P.O. BOX 0789 Kirkland, WA 98083 -0789 |
| Contact | Gerald Mcmarrow |
| Correspondent | Gerald Mcmarrow DIAGNOSTIC ULTRASOUND CORP. P.O. BOX 0789 Kirkland, WA 98083 -0789 |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-23 |
| Decision Date | 1991-01-28 |