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FDA 510(k), K203086, X-PLO2R
FDA 510(k), K203086, X-PLO2R
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510(K) Number: K203086
Device Name: X-PLO2R
Manufacturer: Belluscura LLC
Device Classification Name: generator, oxygen, portable
Regulation Number: 868.5440
Classification Product Code: CAW
Date Received: 10/13/2020
Decision Date: 03/02/2021
Regulation Medical Specialty: Anesthesiology
Device Name: X-PLO2R
Manufacturer: Belluscura LLC
Device Classification Name: generator, oxygen, portable
Regulation Number: 868.5440
Classification Product Code: CAW
Date Received: 10/13/2020
Decision Date: 03/02/2021
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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