The following data is part of a premarket notification filed by Verathon Incorporated with the FDA for Verathon Inc. Bladderscan Ultrasound System, Model Bvi 9600.
| Device ID | K082456 |
| 510k Number | K082456 |
| Device Name: | VERATHON INC. BLADDERSCAN ULTRASOUND SYSTEM, MODEL BVI 9600 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | VERATHON INCORPORATED 20001 NORTH CREEK PKWY Bothel, WA 98011 |
| Contact | Richard A Zeine |
| Correspondent | Richard A Zeine VERATHON INCORPORATED 20001 NORTH CREEK PKWY Bothel, WA 98011 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-26 |
| Decision Date | 2008-12-01 |
| Summary: | summary |