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
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
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