The following data is part of a premarket notification filed by Diagnostic Ultrasound Corp. with the FDA for Bladderscan Bvi 2500.
| Device ID | K915436 |
| 510k Number | K915436 |
| Device Name: | BLADDERSCAN BVI 2500 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| 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 | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-04 |
| Decision Date | 1992-03-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10879123005660 | K915436 | 000 |
| 00879123005533 | K915436 | 000 |
| 10879123002591 | K915436 | 000 |
| 10879123002577 | K915436 | 000 |
| 10879123002508 | K915436 | 000 |
| 00879123002297 | K915436 | 000 |
| 10879123002232 | K915436 | 000 |