FDA 510(K) K131686, INOMAX DSIR (DELIVERY SYSTEM)

FDA 510(K) K131686, INOMAX DSIR (DELIVERY SYSTEM)

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Device Classification Name    Apparatus, Nitric Oxide Delivery
510(k) Number    K131686
Device Name    INOMAX DSIR (DELIVERY SYSTEM)
Applicant    INO THERAPEUTICS/IKARIA
Regulation Number    868.5165
Classification Product Code    MRN  
Subsequent Product Codes    MRP      MRQ  
Date Received    06/10/2013
Decision Date    11/29/2013
Decision    Substantially Equivalent (SESE)
Regulation Medical Specialty    Anesthesiology

Total pages: 3,363  
Fully redacted pages: 3,112  
Content pages: 251 

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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