FDA 510(k) K231620, Nuubo Smart, by Smart Solutions Technologies SL

FDA 510(k) K231620, Nuubo Smart, by Smart Solutions Technologies SL

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Device Classification Name: Computer, Diagnostic, Programmable
510(k) Number: K231620
Device Name: Nuubo Smart
Applicant: Smart Solutions Technologies SL
Regulation Number: 870.1425
Classification Product Code: DQK
Date Received: 2023-06-02
Decision Date: 2023-08-01
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
510k Review Panel: Cardiovascular

Total number of pages: 2,276
Fully redacted pages: 1,887
Content pages: 389

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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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