FDA 510(k)

HotDog Warming Mattress + Return Electrode

Número K: K210727 · 2022-02-01

RequerenteAugustine Temperature Management, LLC

Data da decisão2022-02-01

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

HotDog Warming Mattress + Return Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Augustine Temperature Management, LLC. It received FDA 510(k) clearance on 2022-02-01 under 510(k) number K210727. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the HotDog Warming Mattress + Return Electrode?

HotDog Warming Mattress + Return Electrode is a medical device that received FDA 510(k) clearance on 2022-02-01. The listed applicant is Augustine Temperature Management, LLC. The 510(k) number is K210727.

When did HotDog Warming Mattress + Return Electrode receive FDA 510(k) clearance?

HotDog Warming Mattress + Return Electrode received FDA 510(k) clearance on 2022-02-01, under 510(k) number K210727.

Who is the listed applicant for HotDog Warming Mattress + Return Electrode?

The FDA 510(k) record lists Augustine Temperature Management, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HotDog Warming Mattress + Return Electrode?

The FDA product code for HotDog Warming Mattress + Return Electrode is GEI.

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Outros registros que listam Augustine Temperature Management, LLC como candidato(a)

K232627HotDog Warming Mattress + Return Electrode K230866HotDog Warming Mattress + Return Electrode

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Fonte oficial

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