FDA 510(k) Applications for Medical Device Product Code "QGL"

FDA 510(k) Number Applicant Device Name Decision Date
K232991 Bistos Co., Ltd. BT-1000 08/28/2024
DEN180041 NeuroSigma, Inc Monarch eTNS System 04/19/2019
K233293 NeuroSigma, Inc. Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System« 01/16/2024
K243289 Nu Eyne Co., Ltd. ADDNOX (BPSPM1) 01/16/2025
K213629 Nu Eyne Co., Ltd. SMILE 02/12/2023


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