FDA 510(k), K143617, AquaC UNO H

FDA 510(k), K143617, AquaC UNO H

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510(K) Number: K143617
Device Name: AquaC UNO H
Manufacturer: VIVONIC GMBH
Device Classification Name: Subsystem, Water Purification
Regulation Number: 876.5665
Classification Product Code: FIP
Date Received: 12/19/2014
Decision Date: 10/19/2015
Regulation Medical Specialty: Gastroenterology/Urology

Total Pages: 2,374
Fully Redacted Pages: 2,104
Content Pages: 270

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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