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FDA 510(k), K032818, INOGEN ONE OXYGEN CONCENTRATOR
FDA 510(k), K032818, INOGEN ONE OXYGEN CONCENTRATOR
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510(K) Number: K032818
Device Name: INOGEN ONE OXYGEN CONCENTRATOR
Manufacturer: INOGEN, INC.
Device Classification Name: generator, oxygen, portable
Regulation Number: 868.5440
Classification Product Code: CAW
Date Received: 09/10/2003
Decision Date: 05/13/2004
Regulation Medical Specialty: Anesthesiology
Device Name: INOGEN ONE OXYGEN CONCENTRATOR
Manufacturer: INOGEN, INC.
Device Classification Name: generator, oxygen, portable
Regulation Number: 868.5440
Classification Product Code: CAW
Date Received: 09/10/2003
Decision Date: 05/13/2004
Regulation Medical Specialty: Anesthesiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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