FDA 510(k) K150930, Deployable Oxygen Generation System-Smaill (DOGS-S), by Airsep Corporation

FDA 510(k) K150930, Deployable Oxygen Generation System-Smaill (DOGS-S), by Airsep Corporation

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Device Classification Name: Generator, Oxygen, Portable
510(k) Number: K150930
Device Name: Deployable Oxygen Generation System-Smaill (DOGS-S)
Applicant: Airsep Corporation
Regulation Number: 868.544
Classification Product Code: CAW
Date Received: 2015-04-06
Decision Date: 2015-12-18
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
510k Review Panel: Anesthesiology

Total number of pages: 3,238
Fully redacted pages: 2,840
Content pages: 398

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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