21 CFR 884.2600 - Fetal cardiac monitor.

§ 884.2600 Fetal cardiac monitor.

(a)Identification. A fetal cardiac monitor is a device used to ascertain fetal heart activity during pregnancy and labor. The device is designed to separate fetal heart signals from maternal heart signals by analyzing electrocardiographic signals (electrical potentials generated during contraction and relaxation of heart muscle) obtained from the maternal abdomen with external electrodes. This generic type of device may include an alarm that signals when the heart rate crosses a preset threshold. This generic type of device includes the “fetal cardiotachometer (with sensors)” and the “fetal electrocardiographic monitor.”

(b)Classification. Class II (performance standards).

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United States Code

Title 21 published on 09-Jun-2018 03:51

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

  • 2018-06-05; vol. 83 # 108 - Tuesday, June 5, 2018
    1. 83 FR 25910 - Medical Devices; Exemptions From Premarket Notification: Class II Devices
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective June 5, 2018.
      21 CFR Parts 862, 866, 876, 880, and 884
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