Translating FDA Searches - Neonatal incubator weigh scales

qu1nn

Involved In Discussions
#1
Hello,

I am doing some research on neonatal incubator weigh scales and I have some questions about the following image:

https://s22.postimg.cc/cz9mfmuq9/20180809_elsmar_question2.png

Am I correct in the way that I am interpreting what is coming up in the search?

Overall the product category appears to be a weigh scale (product code FRW, class 1 with NO 510(k) requirement),
but it is also a neonatal incubator (implied; product code FMZ, class 2, with a 510(k) requirement) ,since this feature is of a higher risk (being a class 2) the company would of had to submit 510(k) to the FDA and it was it was reviewed and found to be in compliance by the "general hospital" 510(k) panel.


Does anyone know if there is there a way to view the 510(k) reports that are shown on the FDA searches?

Thanks for your time
qu1nn
 

qu1nn

Involved In Discussions
#3
Go to FDA's 510(k) Premarket Notification database 510(k) Premarket Notification and search for the product code or a device name.
thanks mihzago,



I have already posted the output of that search in my original image link (its the bottom picture); I was hoping to find out in depth details and whether or not you can actually get the report. seems as if the output is only a summary. there are no more links provided.


thanks for your time
qu1nn
 

Al Rosen

Staff member
Super Moderator
#4
thanks mihzago,



I have already posted the output of that search in my original image link (its the bottom picture); I was hoping to find out in depth details and whether or not you can actually get the report. seems as if the output is only a summary. there are no more links provided.


thanks for your time
qu1nn
You will need to make an FOIA request to the FDA for more than the summary. Receiving the information will take quite some time, since the 510(k) holder is notified and supplies a redacted copy removing proprietary information and trade secrets. Some of the 510kk that have already been redacted can be found here CDRH FOIA Electronic Reading Room
 
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qu1nn

Involved In Discussions
#5
You will need to make an FOIA request to the FDA for more than the summary. Receiving the information will take quite some time, since the 510(k) holder is notified and supplies a redacted copy removing proprietary information and trade secrets. Some of the 510kk that have already been redacted can be found here CDRH FOIA Electronic Reading Room
Al,


Thanks for the additional information.


Am I off base on my original assessment of what was posted in the image regarding the product? ( ie being both a FRW and a FMZ product code, thus having the requirement for 510(K)....


Thanks for your input
qu1nn
 

Al Rosen

Staff member
Super Moderator
#6
Al,


Thanks for the additional information.


Am I off base on my original assessment of what was posted in the image regarding the product? ( ie being both a FRW and a FMZ product code, thus having the requirement for 510(K)....


Thanks for your input
qu1nn
I think your assessment is correct.
 

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