ETP · Class I · 21 CFR 874.1800

FDA Product Code ETP: Stimulator, Caloric-water

Leading manufacturers include Jedmed Instrument Co. and Life-Tech Intl., Inc..

6
Total
6
Cleared
71d
Avg days
1980
Since

FDA 510(k) Cleared Stimulator, Caloric-water Devices (Product Code ETP)

6 devices
1–6 of 6
Cleared Dec 16, 1986
ENTHERMO IRRIGATION UNIT
K863615
Jedmed Instrument Co.
Ear, Nose, Throat · 91d
Cleared Nov 03, 1982
VESTIBULARISET
K820775
Jedmed Instrument Co.
Ear, Nose, Throat · 225d
Cleared Feb 22, 1982
MODEL 3000C CALORIC IRRIGATOR
K813552
Life-Tech Intl., Inc.
Ear, Nose, Throat · 63d
Cleared Mar 10, 1980
VARIOTHERM
K800442
Jedmed Instrument Co.
Ear, Nose, Throat · 11d
Cleared Mar 10, 1980
HYGROTHERM
K800443
Jedmed Instrument Co.
Ear, Nose, Throat · 11d

About Product Code ETP - Regulatory Context