FDA 510(k), K213037, IDx-DR v2.3

FDA 510(k), K213037, IDx-DR v2.3

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510(K) Number: K213037
Device Name: IDx-DR v2.3
Manufacturer: Digital Diagnostics Inc.
Device Classification Name: Diabetic Retinopathy Detection Device
Regulation Number: 886.1100
Classification Product Code: PIB
Date Received: 09/21/2021
Decision Date: 06/17/2022
Regulation Medical Specialty: Ophthalmic

Total pages: 9294
Fully redacted pages: 8968
Content pages: 326

PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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