Product code LXV ยท Class U
Apparatus, Vestibular Analysis
0510(k)s in 12 months (22 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in LXV
| Company | 510(k)s | Recalls |
|---|---|---|
| Interacoustics A/S | 3 | 0 |
| Micromedical Technologies, Inc. | 2 | 0 |
| Acacia Engineered Products LLC | 0 | 1 |
| Breg, Inc. | 1 | 0 |
| Capacity Sports, LLC | 1 | 0 |
| Chattanooga Group, Inc. | 1 | 0 |
| Clearwater Clinical Limited | 1 | 0 |
| Contraves | 1 | 0 |
| Contraves Goerz Corp. | 1 | 0 |
| Ics Medical Corp. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2009 | Neuro Kinetics VEST 6.6 or earlier software for use with Neuro Kinetics products.
The device is used for vestibular testing. Terminated |
LXV | K083603 |
| Sep 17, 2008 | Acacia Engineered Products LLC Isotechnology, Isobalance System; Serial Numbers: 07-030. The product was being investigated as a device to determine possible inner ear problems. Terminated |
LXV | None listed |
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