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
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