Product code EWC— Ear, Nose, Throat

EMERGENCY TRACHEOSTOMY KIT

Classification name: Chamber, Acoustic (For Audiometric Testing)
Device class: Class 1
Regulation: 21 CFR 874.1060
Advisory panel: Ear, Nose, Throat
Total cleared: 2
First cleared: 1982-09-09
Most recent: 1983-01-21

Market context for product code EWC

FDA has cleared 2 devices under product code EWC between 1982 and 1983, 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

19831 clearance
19821 clearance

Top applicants under product code EWC

Omnicon Medical Corp.1 clearance
Kelleher Corp.1 clearance

Recent clearances under product code EWC

K823872 — EMERGENCY TRACHEOSTOMY KITOmnicon Medical Corp.·1983-01-21
K822269 — NAGASHIMA SN SOUND-PROOF CHAMBER-HEARINGKelleher Corp.·1982-09-09

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