DeviceClearance

Product code ERA— Ear, Nose, Throat

OTOSCOPE

Classification name
Otoscope
Device class
Class 1
Regulation
21 CFR 874.4770
Advisory panel
Ear, Nose, Throat
Total cleared
56
First cleared
Most recent

Market context for product code ERA

FDA has cleared 56 devices under product code ERA between 1977 and 2013, filed by 31 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

last 15 years

Top applicants under product code ERA

Recent clearances under product code ERA

Data sourced from openFDA. This site is unofficial and independent of the FDA.