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FDA 510(k) K982412, MODIFICATION OF CRIT-LINE MONITOR III (CLM III), by In-Line Diagnostics Corp.

FDA 510(k) K982412, MODIFICATION OF CRIT-LINE MONITOR III (CLM III), by In-Line Diagnostics Corp.

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510(K) Number: K982412
Device Name: MODIFICATION OF CRIT-LINE MONITOR III (CLM III)
Manufacturer: In-Line Diagnostics Corp.
Device Classification Name: System, Hemodialysis, Access Recirculation Monitoring
Regulation Number: 876.5820
Classification Product Code: MQS
Date Received: 07/13/1998
Decision Date: 10/09/1998
Regulation Medical Specialty: Gastroenterology/Urology

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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