FDA 510(k), K213507, AquaA

FDA 510(k), K213507, AquaA

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510(K) Number: K213507
Device Name: AquaA
Manufacturer: Fresenius Medical Care Rental Therapies Group, LLC
Device Classification Name: Subsystem, Water Purification
Regulation Number: 876.5665
Classification Product Code: FIP
Date Received: 11/01/2021
Decision Date: 07/27/2022
Regulation Medical Specialty: Gastroenterology/Urology

Total Pages: 5,340
Fully Redacted Pages: 4,586
Content Pages: 754

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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