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FDA 510(k), K121891, NEWPORT AURA VENTILATOR
FDA 510(k), K121891, NEWPORT AURA VENTILATOR
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$149.00 USD
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510(K) Number: K121891
Device Name: NEWPORT AURA VENTILATOR
Manufacturer: NEWPORT MEDICAL INSTRUMENTS, INC.
Device Classification Name: ventilator, continuous, facility use
Regulation Number: 868.5895
Classification Product Code: CBK
Date Received: 06/29/2012
Decision Date: 11/09/2012
Regulation Medical Specialty: Anesthesiology
Device Name: NEWPORT AURA VENTILATOR
Manufacturer: NEWPORT MEDICAL INSTRUMENTS, INC.
Device Classification Name: ventilator, continuous, facility use
Regulation Number: 868.5895
Classification Product Code: CBK
Date Received: 06/29/2012
Decision Date: 11/09/2012
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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