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U.S. FDA Medical Device Home Uterine Activity Monitor Requirements: Home Uterine Activity Monitor

FDA Medical Device Definition: A home uterine activity monitor (HUAM) is an electronic system for at home antepartum measurement of uterine contractions, data transmission by telephone to a clinical setting, and for receipt and display of the uterine contraction data at the clinic. The HUAM system comprises a tocotransducer, an at-home recorder, a modem, and a computer and monitor that receive, process, and display data. This device is intended for use in women with a previous preterm delivery to aid in the detection of preterm labor

Registrar Corp assists Home Uterine Activity Monitor companies with:

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