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FDA 510(k)

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

K-Number: K233501 · 2024-07-26

ApplicantLargan Medical Co., Ltd.
Decision Date2024-07-26
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Largan Medical Co., Ltd.. The 510(k) number is K233501.

When was “LARGAN Health AI-Tech” Sleep Apnea and Sleep Quality Examination System (ST-SLP03A) approved by the FDA?

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

What company makes “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 manufactured by Largan Medical Co., Ltd..

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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Related PubMed Literature

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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