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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilatory Effort Recorder
510(k) Number K233501
Device Name “LARGAN Health AI-Tech” Sleep Apnea and Sleep Quality Examination System (ST-SLP03A)
Applicant
Largan Medical Co., Ltd.
2f., # 14. 23rd., Taichung Industrial Park, Nantun Dist.,
Taichung,  TW 40805
Applicant Contact Shih-min Chen
Correspondent
Largan Medical Co., Ltd.
2f., # 14. 23rd., Taichung Industrial Park, Nantun Dist.,
Taichung,  TW 40805
Correspondent Contact Shih-min Chen
Regulation Number868.2375
Classification Product Code
MNR  
Date Received10/31/2023
Decision Date 07/26/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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