21 CFR 882.4565 — Field Generator Positioning Device
Neurology (NE) · Part 882 Subpart E—Neurological Surgical Devices · § 882.4565
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QLV | Field Generator Positioning Device | 1 | 0 |
