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).

Title 21 published on 2014-04-01

no entries appear in the Federal Register after this date.

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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 884 after this date.

  • 2014-05-01; vol. 79 # 84 - Thursday, May 1, 2014
    1. 79 FR 24634 - Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair and Surgical Instrumentation for Urogynecologic Surgical Mesh Procedures; Designation of Special Controls for Urogynecologic Surgical Mesh Instrumentation
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Proposed order.
      Submit either electronic or written comments on this proposed order by July 30, 2014. Please see section XIII for the proposed effective date of any final order that may publish based on this proposal.
      21 CFR Part 884