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U.S. FDA Medical Device Laryngostroboscope Requirements

FDA Medical Device Definition: A laryngostroboscope is a device that is intended to allow observation of glottic action during phonation. The device operates by focusing a stroboscopic light through a lens for direct or mirror reflected viewing of glottic action. The light and microphone that amplifies acoustic signals from the glottic area may or may not contact the patient.

Registrar Corp assists Laryngostroboscope companies with:

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

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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