21 CFR 884.2960 - Obstetric ultrasonic transducer and accessories.

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There is 1 rule appearing in the Federal Register for 21 CFR Part 884. View below or at eCFR (GPOAccess)
§ 884.2960 Obstetric ultrasonic transducer and accessories.
(a) Identification. An obstetric ultrasonic transducer is a device used to apply ultrasonic energy to, and to receive ultrasonic energy from, the body in conjunction with an obstetric monitor or imager. The device converts electrical signals into ultrasonic energy, and vice versa, by means of an assembly distinct from an ultrasonic generator. This generic type of device may include the following accessories: coupling gel, preamplifiers, amplifiers, signal conditioners with their power supply, connecting cables, and component parts. This generic type of device does not include devices used to generate the ultrasonic frequency electrical signals for application.
(b) Classification. Class II (performance standards).

Title 21 published on 2014-04-01.

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2015-02-26; vol. 80 # 38 - Thursday, February 26, 2015
    1. 80 FR 10330 - Medical Devices; Obstetrical and Gynecological Devices; Classification of the Assisted Reproduction Embryo Image Assessment System
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective February 26, 2015. The classification was applicable June 6, 2014.
      21 CFR Part 884

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United States Code

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 884 after this date.

  • 2015-02-26; vol. 80 # 38 - Thursday, February 26, 2015
    1. 80 FR 10330 - Medical Devices; Obstetrical and Gynecological Devices; Classification of the Assisted Reproduction Embryo Image Assessment System
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective February 26, 2015. The classification was applicable June 6, 2014.
      21 CFR Part 884