FDA 510(k)

“LARGAN Health AI-Tech” Sleep Apnea and Sleep Quality Examination System (ST-SLP03A)

Número K: K233501 · 2024-07-26

Data da decisão2024-07-26

Código do produtoMNR

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

“LARGAN Health AI-Tech” Sleep Apnea and Sleep Quality Examination System (ST-SLP03A) is the device name listed in this FDA 510(k) record. The listed applicant is Largan Medical Co., Ltd.. It received FDA 510(k) clearance on 2024-07-26 under 510(k) number K233501. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the “LARGAN Health AI-Tech” Sleep Apnea and Sleep Quality Examination System (ST-SLP03A)?

“LARGAN Health AI-Tech” Sleep Apnea and Sleep Quality Examination System (ST-SLP03A) is a medical device that received FDA 510(k) clearance on 2024-07-26. The listed applicant is Largan Medical Co., Ltd.. The 510(k) number is K233501.

When did “LARGAN Health AI-Tech” Sleep Apnea and Sleep Quality Examination System (ST-SLP03A) receive FDA 510(k) clearance?

“LARGAN Health AI-Tech” Sleep Apnea and Sleep Quality Examination System (ST-SLP03A) received FDA 510(k) clearance on 2024-07-26, under 510(k) number K233501.

Who is the listed applicant for “LARGAN Health AI-Tech” Sleep Apnea and Sleep Quality Examination System (ST-SLP03A)?

The FDA 510(k) record lists Largan Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for “LARGAN Health AI-Tech” Sleep Apnea and Sleep Quality Examination System (ST-SLP03A)?

The FDA product code for “LARGAN Health AI-Tech” Sleep Apnea and Sleep Quality Examination System (ST-SLP03A) is MNR.

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