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510(k) K233501

“LARGAN Health AI-Tech” Sleep Apnea and Sleep Quality Examination System (ST-SLP03A) by Largan Medical Co., Ltd. — Product Code MNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2024
Date Received
October 31, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilatory Effort Recorder
Device Class
Class II
Regulation Number
868.2375
Review Panel
AN
Submission Type

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