QJG — Device System, Imaging, Tympanic Membrane And Middle Ear Class II
FDA product code QJG covers "Device System, Imaging, Tympanic Membrane And Middle Ear", a Class II medical device regulated under 21 CFR 892.1560. Submissions are reviewed by the Radiology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QJG
- Device Class
- Class II
- Regulation Number
- 892.1560
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Radiology
- Implant
- No
Definition
Is intended for use as an imaging tool for visualization of the human tympanic membrane and middle ear space.