Hygrotherm

FDA 510(k) K800443 · Jedmed Instrument Co.

Substantially Equivalent

510(k) numberK800443

Submission

Device name
Hygrotherm
Applicant
Jedmed Instrument Co.
Mchenry, IL, US
Received
February 28, 1980
Decision date
March 10, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
ETP – Stimulator, Caloric-Water
Device class
Class I (low risk)
Regulation
21 CFR 874.1800
Specialty
Ear, Nose, Throat

Other 510(k)s with product code ETP

510(k)DeviceApplicantDecision
K863615Enthermo Irrigation UnitETP · Traditional Jedmed Instrument Co.12/16/1986SE
K820775VestibularisetETP · Traditional Jedmed Instrument Co.11/03/1982SE
K821481Nasal-Throat Spray Irrigation Instrum.ETP · Traditional Ethicare Products06/14/1982SE
K813552Model 3000C Caloric IrrigatorETP · Traditional Life-Tech Intl., Inc.02/22/1982SE
K800442VariothermETP · Traditional Jedmed Instrument Co.03/10/1980SE

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K950925Jedmed Laryngeal ScopeEOQ · Traditional 08/11/1995SE
K950785Hortmann Airmatic Air Caloric StimulatorKHH · Traditional 06/28/1995SE
K950078Microflow Irrigation SystemKMA · Traditional 06/21/1995SE
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Questions and answers

When was Hygrotherm cleared by the FDA?

Hygrotherm (K800443) received a 510(k) decision of Substantially Equivalent on March 10, 1980, 11 days after the submission was received.

What is the product code of K800443?

The FDA product code is ETP – Stimulator, Caloric-Water, a Class I (low risk) device regulated under 21 CFR 874.1800.