FDA 510(k)

Skin Air Cooling System (QALF-01)

Número K: K261674 · 2026-07-16

Data da decisão2026-07-16

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Skin Air Cooling System (QALF-01) is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Nubway S&T Co., Ltd.. It received FDA 510(k) clearance on 2026-07-16 under 510(k) number K261674. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Skin Air Cooling System (QALF-01)?

Skin Air Cooling System (QALF-01) is a medical device that received FDA 510(k) clearance on 2026-07-16. The listed applicant is Beijing Nubway S&T Co., Ltd.. The 510(k) number is K261674.

When did Skin Air Cooling System (QALF-01) receive FDA 510(k) clearance?

Skin Air Cooling System (QALF-01) received FDA 510(k) clearance on 2026-07-16, under 510(k) number K261674.

Who is the listed applicant for Skin Air Cooling System (QALF-01)?

The FDA 510(k) record lists Beijing Nubway S&T Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Skin Air Cooling System (QALF-01)?

The FDA product code for Skin Air Cooling System (QALF-01) is GEX. This falls under the Gastroenterology category.

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Fonte oficial

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