EWA — Set, Audiometer Calibration Class I
FDA product code EWA covers "Set, Audiometer Calibration", a Class I medical device regulated under 21 CFR 874.1080. Submissions are reviewed by the Ear, Nose, Throat panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification details
- Product Code
- EWA
- Device Class
- Class I
- Regulation Number
- 874.1080
- Submission Type
- 510(k) Exempt
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No