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FDA 510(k), K171827, ReddyPort NIV Access Elbow
FDA 510(k), K171827, ReddyPort NIV Access Elbow
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510(K) Number: K171827
Device Name: ReddyPort NIV Access Elbow
Manufacturer: SMD Manufacturing, LLC
Device Classification Name: ventilator, continuous, non-life-supporting
Regulation Number: 868.5895
Classification Product Code: MNS
Date Received: 06/20/2017
Decision Date: 01/19/2018
Regulation Medical Specialty: Anesthesiology
Device Name: ReddyPort NIV Access Elbow
Manufacturer: SMD Manufacturing, LLC
Device Classification Name: ventilator, continuous, non-life-supporting
Regulation Number: 868.5895
Classification Product Code: MNS
Date Received: 06/20/2017
Decision Date: 01/19/2018
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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