The following data is part of a premarket notification filed by Diagnostic Ultrasound Corp. with the FDA for Bladderscan Bvi 5000.
| Device ID | K955942 |
| 510k Number | K955942 |
| Device Name: | BLADDERSCAN BVI 5000 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | DIAGNOSTIC ULTRASOUND CORP. 18109 NE 76TH ST. Redmond, WA 98052 |
| Contact | Gerald Mcmorrow |
| Correspondent | Gerald Mcmorrow DIAGNOSTIC ULTRASOUND CORP. 18109 NE 76TH ST. Redmond, WA 98052 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-26 |
| Decision Date | 1996-03-15 |
| Summary: | summary |