Registrar Corp

HomeMedical Devices510(k) Administrative ReviewMedical Device 510(k) Examples › U.S. FDA Fetal Ultrasonic Monitor and Accessories Regulations

U.S. FDA Medical Device Fetal Ultrasonic Monitor and Accessories Requirements: Fetal Ultrasonic Monitor and Accessories

FDA Medical Device Definition: A fetal ultrasonic monitor is a device designed to transmit and receive ultrasonic energy into and from the pregnant woman, usually by means of continuous wave (doppler) echoscopy. The device is used to represent some physiological condition or characteristic in a measured value over a period of time (e.g., perinatal monitoring during labor) or in an immediately perceptible form (e.g., use of the ultrasonic stethoscope). This generic type of device may include the following accessories: signal analysis and display equipment, electronic interfaces for other equipment, patient and equipment supports, and component parts. This generic type of device does not include devices used to image some relatively unchanging physiological structure or interpret a physiological condition, but does include devices which may be set to alarm automatically at a predetermined threshold value

Registrar Corp assists Fetal Ultrasonic Monitor and Accessories companies with:

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




Live Help

 
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.
Home | About Us | News | Resources | Exhibitions | Seminars | Associations | Careers | Sitemap | Terms of Use © 2016 Registrar Corp
 
Food and Beverages | Drugs | Cosmetics | Medical Devices | Radiation-Emitting Electronic Devices | Color Additives | Tobacco