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We manage the entire review process for each applicant from the time of formal submission through the final substantial equivalence determination rendered by FDA. In this case, if you dont have a sufficient database capacity of at least 1 GB, you will not be able to create a new environment and you only have the below three options: Free up storage to have at least 1 GB database capacity to be able to create a new environment.Note that we have far more detailed data available about these products and also have databases of other product categories in the wider digital health field. a1 WipakSubmitters name, address, telephone number, a contact person, and the date the summary was prepared Oy Wipaktie 2 Nastola Finland Contacts: Hanna Marttila, Phone: 358 (0) Mr. Applicants submit their 510(k) directly to TPRG in lieu of FDA saving them precious review time and expediting their device clearance into US commerce. In the gallery below you can browse our curated database of regulated mobile medical health apps (FDA approved and CE mark). 510K Summary (in accordance with 21CFR807.92) 510K Summary Elements per 21CFR807.92 Summary.
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#510k database how to#
You can read another blog we wrote to explain Special Controls Guidance documents, and how to determine if one applies to your device. Your first step in preparing your 510k submission is to search the FDA Guidance Document Database to determine if there is an applicable guidance document for your device.