FDA was already done in 2014 for the old version- there is no need for FDA "approval" as the product is substantially similar to other products on market, and nothing is ingested- it gets a Substantially Equivalent (SESE) rating.
The Respiri announcement will be exactly the same- if anyone buys on this news they're misinformed... Decision was already public a week ago anyway- you can see it on the FDA website. It's not really a decision anyway...
"We have reviewed your Section 510(k) premarket notification of intent to market the device
referenced above and have determined the device is substantially equivalent (for the indications
for use stated in the enclosure) to legally marketed predicate devices marketed in interstate
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to
devices that have been reclassified in accordance with the provisions of the Federal Food, Drug,
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).
You may, therefore, market the device, subject to the general controls provisions of the Act."
- Forums
- ASX - By Stock
- Ann: Trading Halt
FDA was already done in 2014 for the old version- there is no...
-
- There are more pages in this discussion • 79 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
Featured News
Add RSH (ASX) to my watchlist
|
|||||
Last
2.9¢ |
Change
0.002(7.41%) |
Mkt cap ! $37.25M |
Open | High | Low | Value | Volume |
2.7¢ | 2.9¢ | 2.7¢ | $5.276K | 192.2K |
Buyers (Bids)
No. | Vol. | Price($) |
---|---|---|
1 | 500000 | 2.7¢ |
Sellers (Offers)
Price($) | Vol. | No. |
---|---|---|
2.9¢ | 147741 | 2 |
View Market Depth
No. | Vol. | Price($) |
---|---|---|
1 | 500000 | 0.027 |
6 | 292305 | 0.026 |
3 | 799992 | 0.025 |
1 | 250000 | 0.024 |
2 | 68161 | 0.023 |
Price($) | Vol. | No. |
---|---|---|
0.029 | 147741 | 2 |
0.030 | 626201 | 2 |
0.033 | 18333 | 1 |
0.034 | 400000 | 1 |
0.035 | 214456 | 2 |
Last trade - 16.10pm 16/08/2024 (20 minute delay) ? |
Featured News
RSH (ASX) Chart |