FDA 510(k)

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

K-번호: K233501 · 2024-07-26

결정일2024-07-26

제품 코드MNR

자문 위원회안내: 의료기기 규제 문서 번역 요청입니다. 회사명, 제품명, FDA, 510(k), PMA, NCT, PMID, 식별자 및 URL을 보존하여 번역하여 주세요. 정책: 의료규제-v1. [원문] AN [번역] 안내

결정Substantially Equivalent

기기 요약

“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.

자주 묻는 질문

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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