VERATHON INC. BLADDERSCAN ULTRASOUND SYSTEM, MODEL BVI 9600
FDA 510(k) clearance K082456 · decided 2008-12-01
Clearance details
- K-number
- K082456
- Device name
- VERATHON INC. BLADDERSCAN ULTRASOUND SYSTEM, MODEL BVI 9600
- Applicant
- Verathon Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2008-08-26
- Decision date
- 2008-12-01
- Days to decision
- 97 days
- Clearance type
- Abbreviated
- Product code
- IYO
- Device class
- 2
- Regulation number
- 892.1560
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Bothell, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaSca recall (Z-0003-2011) | Verathon, Inc. | 2010-10-04 |
| AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects ultrasound recall (Z-0004-2011) | Verathon, Inc. | 2010-10-04 |