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FDA 510(k), K182874, Fenom Pro Nitric Oxide Test
FDA 510(k), K182874, Fenom Pro Nitric Oxide Test
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$149.00 USD
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510(K) Number: K182874
Device Name: Fenom Pro Nitric Oxide Test
Manufacturer: Spirosure, Inc.
Device Classification Name: system, test, breath nitric oxide
Regulation Number: 862.3080
Classification Product Code: MXA
Date Received: 10/12/2018
Decision Date: 02/13/2019
Regulation Medical Specialty: Toxicology
Device Name: Fenom Pro Nitric Oxide Test
Manufacturer: Spirosure, Inc.
Device Classification Name: system, test, breath nitric oxide
Regulation Number: 862.3080
Classification Product Code: MXA
Date Received: 10/12/2018
Decision Date: 02/13/2019
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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