by Jean Roth , jroth@nber.org , 15 Oct 2018
The device name variable contains descriptions associated with the product codes.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/ThirdParyReview/default.htm
Further information on this program can be found at: Third Party Review
the following codes reflect whether it became eligible under the preexisting program or the expansions program.
When the device is a candidate for Third Party Review under the Accredited Persons program,
For example, to find a specific pump, search on the word "pump" to retrieve all products with the word "pump" in their name.
Therefore, the first word in the device name is usually the best search parameter.
The Device Name uses the format of a noun that is usually followed by one or more adjectives, separated by commas.
STATEMENT indicates that safety and effectiveness information may be obtained from the 510(k) applicant
SUMMARY indicates that a summary of safety and effectiveness information is available from FDA