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FDA 510(k), K160630, Invacare Platinum Mobile Oxygen Concentrator
FDA 510(k), K160630, Invacare Platinum Mobile Oxygen Concentrator
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$149.00 USD
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510(K) Number: K160630
Device Name: Invacare Platinum Mobile Oxygen Concentrator
Manufacturer: INVACARE CORPORATION
Device Classification Name: generator, oxygen, portable
Regulation Number: 868.5440
Classification Product Code: CAW
Date Received: 03/07/2016
Decision Date: 09/27/2016
Regulation Medical Specialty: Anesthesiology
Device Name: Invacare Platinum Mobile Oxygen Concentrator
Manufacturer: INVACARE CORPORATION
Device Classification Name: generator, oxygen, portable
Regulation Number: 868.5440
Classification Product Code: CAW
Date Received: 03/07/2016
Decision Date: 09/27/2016
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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