21 CFR 870.2600 - Signal isolation system.

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There are 5 Updates appearing in the Federal Register for 21 CFR Part 870. View below or at eCFR (GPOAccess)
§ 870.2600 Signal isolation system.

(a)Identification. A signal isolation system is a device that electrically isolates the patient from equipment connected to the commercial power supply received from a utility company. This isolation may be accomplished, for example, by transformer coupling, acoustic coupling, or optical coupling.

(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001]

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United States Code

Title 21 published on 2015-12-03

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 870 after this date.

  • 2017-01-13; vol. 82 # 9 - Friday, January 13, 2017
    1. 82 FR 4151 - Cardiovascular Devices
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      21 CFR Part 870

Title 21 published on 2015-12-03.

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.

  • 2017-01-13; vol. 82 # 9 - Friday, January 13, 2017
    1. 82 FR 4151 - Cardiovascular Devices
      GPO FDSys: XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      21 CFR Part 870