@glasscricketbat
Interesting choice for predicate. Different mode of operation. This may have been one of the changes which helped them get it cleared second time around. My first 510k, I had the same issue. It's tricky when there isn't an exact type of device like the one being submitted.
Yes, the summary will come out in the next couple of weeks. Will be interesting to read the IFU and see if it differs from the CE Mark version. Also, FDA clearance will help them get approval in some countries which prefer US FDA clearance rather than CE Mark.
@glasscricketbatInteresting choice for predicate. Different mode...
-
- There are more pages in this discussion • 10 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
Add LDX (ASX) to my watchlist
 (20min delay)
|
|||||
|
Last
3.1¢ |
Change
0.001(3.33%) |
Mkt cap ! $14.92M | |||
| Open | High | Low | Value | Volume |
| 3.0¢ | 3.2¢ | 3.0¢ | $59.53K | 1.912M |
Buyers (Bids)
| No. | Vol. | Price($) |
|---|---|---|
| 5 | 1117600 | 3.0¢ |
Sellers (Offers)
| Price($) | Vol. | No. |
|---|---|---|
| 3.2¢ | 490000 | 4 |
View Market Depth
| Last trade - 16.10pm 28/06/2024 (20 minute delay) ? |
| LDX (ASX) Chart |