Rio Salado Community College Medical Devices Discussion
Description
Log onto
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/
and locate the Approvals & Clearances section. Navigate to & then click the 510(k) Clearances. Next, click the 510(k) Devices Cleared in 2019, browse some or all of the monthly clearances. The older clearances have a link to the approval letter, but youll notice that it is a standard letter.
Once youve read a few listings, choose 2 listings, read the approval letter (510(k) NO: followed by blue numbers click on the blue numbers. Research the product online by name of product and manufacturer. Answer the following questions about each product.
A) What is the product and how is it used? Who is the manufacturer? Are you familiar with their products/name?
B) Was the device easy to find online? Paste the link here
C) How does this product fit the definition of a medical device? Why is the device considered a 510(k) device?
D) What did you think of the website? Was it professional, up-to-date and/or informative?
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