21 CFR 882.1890 - Evoked response photic stimulator.

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§ 882.1890 Evoked response photic stimulator.

(a) Identification. An evoked response photic stimulator is a device used to generate and display a shifting pattern or to apply a brief light stimulus to a patient's eye for use in evoked response measurements or for electroencephalogram (EEG) activation.

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

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United States Code

Title 21 published on 2015-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 882 after this date.

  • 2015-08-17; vol. 80 # 158 - Monday, August 17, 2015
    1. 80 FR 49136 - Medical Devices; Neurological Devices; Classification of the Computerized Cognitive Assessment Aid
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective September 16, 2015. The classification was applicable on June 5, 2015.
      21 CFR Part 882