yes ...
here is some more info
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080187.htm
Background
Under section 510(k) of the Act, a person who intends to introduce a device into commercial distribution is required to submit a premarket notification, or 510(k), to FDA at least 90 days before commercial distribution is to begin. Section 513(i) of the Act states that FDA may issue an order of substantial equivalence only upon making a determination that the device to be introduced into commercial distribution is as safe and effective as a legally marketed device. Under 21 CFR 807.87, FDA established the content requirements for premarket notifications to be submitted by device manufacturers in support of the substantial equivalence decision. FDA has, however, discretion in the type of information it deems necessary to meet those content requirements. For example, to allocate review resources more effectively to the highest risk devices, FDA developed a tiering system based on the complexity and the level of risk posed by medical devices. Under this system, the substantial equivalence determination for low risk devices is based primarily on descriptive information and a labeling review, while the decision for higher risk devices relies on performance data.
so this device in my opinion is low risk as it receives patient data like heart rate, but in receiving it..it is unlikely to be the only device
- Forums
- ASX - By Stock
- indicative, conditional, non-binding proposal
yes ...here is some more...
Featured News
Add AHC (ASX) to my watchlist
(20min delay)
|
|||||
Last
24.3¢ |
Change
-0.003(1.02%) |
Mkt cap ! $89.19M |
Open | High | Low | Value | Volume |
24.5¢ | 24.5¢ | 24.0¢ | $43.11K | 178.9K |
Buyers (Bids)
No. | Vol. | Price($) |
---|---|---|
1 | 100000 | 24.0¢ |
Sellers (Offers)
Price($) | Vol. | No. |
---|---|---|
24.5¢ | 119098 | 3 |
View Market Depth
No. | Vol. | Price($) |
---|---|---|
3 | 141680 | 0.240 |
2 | 62131 | 0.235 |
3 | 114129 | 0.230 |
1 | 45000 | 0.225 |
4 | 52704 | 0.220 |
Price($) | Vol. | No. |
---|---|---|
0.245 | 119098 | 3 |
0.250 | 296081 | 5 |
0.260 | 50000 | 1 |
0.265 | 305738 | 2 |
0.270 | 350444 | 3 |
Last trade - 11.59am 17/10/2024 (20 minute delay) ? |
Featured News
AHC (ASX) Chart |
The Watchlist
JBY
JAMES BAY MINERALS LIMITED
Andrew Dornan, Executive Director
Andrew Dornan
Executive Director
Previous Video
Next Video
SPONSORED BY The Market Online