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FDA 510(k), K203695, NObreath®
FDA 510(k), K203695, NObreath®
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$149.00 USD
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510(K) Number: K203695
Device Name: NObreath®
Manufacturer: Bedfont Scientific Ltd
Device Classification Name: System, Test, Breath Nitric Oxide
Regulation Number: 862.3080
Classification Product Code: MXA
Date Received: 12/18/2020
Decision Date: 12/17/2021
Regulation Medical Specialty: Toxicology
Device Name: NObreath®
Manufacturer: Bedfont Scientific Ltd
Device Classification Name: System, Test, Breath Nitric Oxide
Regulation Number: 862.3080
Classification Product Code: MXA
Date Received: 12/18/2020
Decision Date: 12/17/2021
Regulation Medical Specialty: Toxicology
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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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