FDA 510K (K990177) NELLCOR PURITAN BENNETT ACHIEVA VENTILATOR AND REPORT GENERATOR

FDA 510K (K990177) NELLCOR PURITAN BENNETT ACHIEVA VENTILATOR AND REPORT GENERATOR

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Device Classification Name    Ventilator, Continuous, Facility Use
510(k) Number    K990177
Device Name    NELLCOR PURITAN BENNETT ACHIEVA VENTILATOR AND REPORT GENERATOR
Applicant     NELLCOR PURITAN BENNETT, INC.
Regulation Number    868.5895
Classification Product Code     CBK  
Date Received    01/19/1999
Decision Date    11/18/1999
Decision    SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty    Anesthesiology

Total pages: 382
Fully redacted pages: 67
Content pages: 315

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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