FDA 510(k) K213134, Accu-Chek Solo micropump system with interoperable technology, by Roche Diabetes Care GmbH

FDA 510(k) K213134, Accu-Chek Solo micropump system with interoperable technology, by Roche Diabetes Care GmbH

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Device Classification Name: Alternate Controller Enabled Insulin Infusion Pump
510(k) Number: K213134
Device Name: Accu-Chek Solo micropump system with interoperable technology
Applicant: Roche Diabetes Care GmbH
Regulation Number: 880.573
Classification Product Code: QFG
Date Received: 2021-09-27
Decision Date: 2023-08-10
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
510k Review Panel: Clinical Chemistry

Total number of pages: 1,500
Fully redacted pages: 1,319
Content pages: 181

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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