Product code EWA— Ear, Nose, Throat
AUDIOMETER CALIBRATOR MODEL RA 310
- Classification name
- Set, Audiometer Calibration
- Device class
- Class 1
- Regulation
- 21 CFR 874.1080
- Advisory panel
- Ear, Nose, Throat
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code EWA
FDA has cleared devices under product code EWA between 1978 and 1994, filed by 2 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1994
- 1978
Top applicants under product code EWA
Recent clearances under product code EWA
Data sourced from openFDA. This site is unofficial and independent of the FDA.