510(k) K082456 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
VERATHON INC. BLADDERSCAN ULTRASOUND SYSTEM, MODEL BVI 9600
| Applicant | Verathon Incorporated, Bothell WA, US |
| Decision | Substantially Equivalent, Dec 1, 2008 |
| Received | Aug 26, 2008 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K082456
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 30, 2015 | Verathon, Inc. BladderScan BVI 9600, Model Numbers: 0270-0451, 0270-0452, 0270-0754, and U270-0451.
AortaScan AMI 9700, Model Numbers: 0270-0636, 0270-0639, and U270-0636. Terminated |
IYO | None listed |
| Oct 4, 2010 | Verathon, Inc. BVI 9600 Bladder Volume Instrument, Aorta Scan Mode
The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the l Terminated |
IYO | None listed |
| Oct 4, 2010 | Verathon, Inc. AortaScan AMI 9700
The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements Terminated |
IYO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.