EWC · Class I · 21 CFR 874.1060

FDA Product Code EWC: Chamber, Acoustic (for Audiometric Testing)

Leading manufacturers include Kelleher Corp. and Omnicon Medical Corp..

2
Total
2
Cleared
34d
Avg days
1982
Since

FDA 510(k) Cleared Chamber, Acoustic (for Audiometric Testing) Devices (Product Code EWC)

2 devices
1–2 of 2
Cleared Jan 21, 1983
EMERGENCY TRACHEOSTOMY KIT
K823872
Omnicon Medical Corp.
Ear, Nose, Throat · 25d
Cleared Sep 09, 1982
NAGASHIMA SN SOUND-PROOF CHAMBER-HEARING
K822269
Kelleher Corp.
Ear, Nose, Throat · 42d

About Product Code EWC - Regulatory Context