Atlas FDA

ETP

6 FDA 510(k) clearances · Product code

63 daysmedian time to decision
225 days90th percentile
6clearances measured

FDA profile

Official device name
Stimulator, Caloric-Water
Device class
Class I (low risk)
Regulation
21 CFR 874.1800
Medical specialty
Ear, Nose, Throat
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RecordFirmDate
ENTHERMO IRRIGATION UNIT (K863615)Jedmed Instrument Co.1986-12-16
VESTIBULARISET (K820775)Jedmed Instrument Co.1982-11-03
NASAL-THROAT SPRAY IRRIGATION INSTRUM. (K821481)Ethicare Products1982-06-14
MODEL 3000C CALORIC IRRIGATOR (K813552)Life-Tech Intl., Inc.1982-02-22
VARIOTHERM (K800442)Jedmed Instrument Co.1980-03-10
HYGROTHERM (K800443)Jedmed Instrument Co.1980-03-10

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Every clearance here is in the API, with alerts when new ones post.