FDA 510K (K190297) Indicator, Biological Sterilization Process

FDA 510K (K190297) Indicator, Biological Sterilization Process

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Device Classification Name    Indicator, Biological Sterilization Process
510(k) Number    K190297
Device Name    Celerity HP Incubator
Applicant    Steris Corporation
Regulation Number    880.2800
Classification Product Code    FRC  
Date Received    02/11/2019
Decision Date    05/14/2019
Decision    Substantially Equivalent (SESE)
Regulation Medical Specialty    General Hospital

Total pages: 678  
Fully redacted pages: 619  
Content pages: 59 

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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