FDA 510(k)

Therm-X Pro, Therm-X AT, Therm-X Pro Athlete

Número K: K181149 · 2018-08-03

Data da decisão2018-08-03

Código do produtoIRP

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

Therm-X Pro, Therm-X AT, Therm-X Pro Athlete is the device name listed in this FDA 510(k) record. The listed applicant is Zenith Technical Innovations. It received FDA 510(k) clearance on 2018-08-03 under 510(k) number K181149. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Therm-X Pro, Therm-X AT, Therm-X Pro Athlete?

Therm-X Pro, Therm-X AT, Therm-X Pro Athlete is a medical device that received FDA 510(k) clearance on 2018-08-03. The listed applicant is Zenith Technical Innovations. The 510(k) number is K181149.

When did Therm-X Pro, Therm-X AT, Therm-X Pro Athlete receive FDA 510(k) clearance?

Therm-X Pro, Therm-X AT, Therm-X Pro Athlete received FDA 510(k) clearance on 2018-08-03, under 510(k) number K181149.

Who is the listed applicant for Therm-X Pro, Therm-X AT, Therm-X Pro Athlete?

The FDA 510(k) record lists Zenith Technical Innovations as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Therm-X Pro, Therm-X AT, Therm-X Pro Athlete?

The FDA product code for Therm-X Pro, Therm-X AT, Therm-X Pro Athlete is IRP.

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Outros registros que listam Zenith Technical Innovations como candidato(a)

K240125Therm-X (Home); Therm-X (AT)K231912Therm-X K193550Therm-X K190854Therm-X

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