QLV — Field Generator Positioning Device Class I
FDA product code QLV covers "Field Generator Positioning Device", a Class I medical device regulated under 21 CFR 882.4565. Submissions are reviewed by the Neurology panel.
Classification Details
- Product Code
- QLV
- Device Class
- Class I
- Regulation Number
- 882.4565
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Neurology
- Implant
- No
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.