The following data is part of a premarket notification filed by Verathon Incorporated with the FDA for Bladderscan Bvi 9400 Ultrasound.
| Device ID | K071217 |
| 510k Number | K071217 |
| Device Name: | BLADDERSCAN BVI 9400 ULTRASOUND |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | VERATHON INCORPORATED 21222 30TH DRIVE SE, STE. 120 Bothell, WA 98021 -7012 |
| Contact | Russ Garrison |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-05-02 |
| Decision Date | 2007-05-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00879123005526 | K071217 | 000 |
| 10879123002973 | K071217 | 000 |
| 10879123002966 | K071217 | 000 |
| 10879123002638 | K071217 | 000 |
| 10879123002256 | K071217 | 000 |
| 10879123001945 | K071217 | 000 |