The following data is part of a premarket notification filed by Diagnostic Ultrasound Corp. with the FDA for Diagnostic Ultrasound Bladdermass Bvm 6500 Ultrasound System.
| Device ID | K030763 |
| 510k Number | K030763 |
| Device Name: | DIAGNOSTIC ULTRASOUND BLADDERMASS BVM 6500 ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | DIAGNOSTIC ULTRASOUND CORP. 21222 30TH DRIVE SE, STE. 120 Bothell, WA 98021 |
| Contact | Nancy Gertlar |
| Correspondent | Heinz J Steneberg TUV RHEINLAND OF NORTH AMERICA, INC. 1279 QUARRY LANE, SUITE A Pleasanton, CA 94566 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-03-11 |
| Decision Date | 2003-03-26 |
| Summary: | summary |