FDA 510(k) Applications Submitted by Linbin Ye

FDA 510(k) Number Submission Date Device Name Applicant
K210019 01/04/2021 Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+ Unimed Medical Supplies, Inc.
K240283 02/01/2024 BubbleViewÖ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR); ViewHub« Video Processor (S13, S13-T, S13-N, S13-S) MacroLux Medical Technology Co., Ltd.
K240978 04/10/2024 SeleneView« Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G) MacroLux Medical Technology Co., Ltd.
K231774 06/16/2023 CoralView« Single-use Digital Flexible Ureteroscope (U10); CoralView« Single-use Digital Flexible Ureteroscope (U10-B); CoralView« Single-use Digital Flexible Ureteroscope (U10-BR); CoralView« Single-use Digital Flexible Ureteroscope (U20); CoralView« Sin MacroLux Medical Technology Co., Ltd.
K233779 11/27/2023 LoopView« Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub« Video Processor (S13) MacroLux Medical Technology Co., Ltd.


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