OEE — Diagnostic Low Electric Field Class III
FDA product code OEE covers "Diagnostic Low Electric Field", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- OEE
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- SU
- Medical Specialty
- Unknown
- Implant
- No
Definition
As an adjunctive tool to guide the shavings of tissue at the margins of the tumor for use in excisional breast surgery to assist in locating the tissue for excision. In addition to other standard methods such as intraoperative imaging and palpation.