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U.S. FDA Medical Device Breathing Frequency Monitor Requirements: Breathing Frequency Monitor

FDA Medical Device Definition: A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in 868.2377

Registrar Corp assists Breathing Frequency Monitor companies with:

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

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


Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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