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U.S. FDA Medical Device Stomach pH Electrode Requirements

FDA Medical Device Definition: A stomach pH electrode is a device used to measure intragastric and intraesophageal pH (hydrogen ion concentration). The pH electrode is at the end of a flexible lead which may be inserted into the esophagus or stomach through the patient's mouth. The device may include an integral gastrointestinal tube.

Registrar Corp assists Stomach pH Electrode companies with:

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