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U.S. FDA Medical Device Ear Oximeter Requirements: Ear Oximeter

FDA Medical Device Definition: An ear oximeter is an extravascular device used to transmit light at a known wavelength(s) through blood in the ear. The amount of reflected or scattered light as indicated by this device is used to measure the blood oxygen saturation

Registrar Corp assists Ear Oximeter companies with:

  • FDA Ear Oximeter Establishment Registration
  • FDA Ear Oximeter Listing
  • FDA Ear Oximeter Label Requirements and Exceptions
  • FDA Ear Oximeter Import Information
  • FDA Ear Oximeter Detentions (Ear Oximeter Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Ear Oximeter Manufacturers (Ear Oximeter Suppliers)
       - Ear Oximeter Distributors
       - Ear Oximeter Processors
       - Ear Oximeter Repackers
       - Ear Oximeter Relabelers
       - Ear Oximeter Exporters
       - Ear Oximeter Importers
For more information about Ear Oximeter Medical Devices, simply click below:

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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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