Field Generator Positioning Device
The Field Generator Positioning Device is a Class 1 neurology accessory or group of accessories that operates independently or adapts existing medical equipment, such as a procedure chair or surgical bed, to manually position the field generator of a navigation system in proximity to a patient during surgical or clinical procedures. It is exempt from 510(k) premarket notification and is regulated under 21 CFR 882.4565, reviewed by the Ear, Nose, and Throat panel within the Neurology medical specialty. The product code is QLV. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QLV
- Device Class
- FDA class 1
- Regulation Number
- 882.4565
- Medical Specialty
- Neurology
- Review Panel
- EN
- Submission Type
- 4
Device Characteristics
Definition
An accessory or a group of accessories that operate independently or adapt existing medical equipment, such as a procedure chair or surgical bed, to manually position the Field Generator of a Navigation System in proximity to a patient.
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.