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Code · CFR · Title 21 — Food and Drugs · Part 882 — Neurological Devices · § 882.4565

§ 882.4565. Field generator positioning device.

90 words·~1 min read·/us/cfr/t21/s§ 882.4565·

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(a)Identification. A field generator positioning device is a manual, mechanical device intended to position the field generator of an electromagnetic based stereotaxic navigation system in proximity to a patient. The device may operate independently or adapt existing medical equipment, such as a procedure chair or surgical bed, by using a mechanical interface.
(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 § 882.9. [90 FR 54234, Nov. 26, 2025]
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§ 882.4565
Field generator positioning device.
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