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U.S. FDA Medical Device Breath Nitric Oxide Test System Requirements: Breath Nitric Oxide Test System

FDA Medical Device Definition: A breath nitric oxide test system is a device intended to measure fractional nitric oxide in human breath. Measurement of changes in fractional nitric oxide concentration in expired breath aids in evaluating an asthma patient's response to anti-inflammatory therapy, as an adjunct to established clinical and laboratory assessments of asthma. A breath nitric oxide test system combines chemiluminescence detection of nitric oxide with a pneumotachograph, display, and dedicated software

Registrar Corp assists Breath Nitric Oxide Test System companies with:

  • FDA Breath Nitric Oxide Test System Establishment Registration
  • FDA Breath Nitric Oxide Test System Listing
  • FDA Breath Nitric Oxide Test System Label Requirements and Exceptions
  • FDA Breath Nitric Oxide Test System Import Information
  • FDA Breath Nitric Oxide Test System Detentions (Breath Nitric Oxide Test System Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Breath Nitric Oxide Test System Manufacturers (Breath Nitric Oxide Test System Suppliers)
       - Breath Nitric Oxide Test System Distributors
       - Breath Nitric Oxide Test System Processors
       - Breath Nitric Oxide Test System Repackers
       - Breath Nitric Oxide Test System Relabelers
       - Breath Nitric Oxide Test System Exporters
       - Breath Nitric Oxide Test System Importers
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U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.


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