FDA 510(k) Applications Submitted by Shenzhen Insighters Medical Technology Co., Ltd.

FDA 510(k) Number Submission Date Device Name Applicant
K242793 09/16/2024 InsightersÖ Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; InsightersÖ Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; InsightersÖ Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; InsightersÖ Insight Shenzhen Insighters Medical Technology Co., Ltd.
K232529 08/21/2023 Disposable Double Lumen Endobronchial Tube Shenzhen Insighters Medical Technology Co., Ltd.
K232580 08/25/2023 Disposable Endobronchial Blocker Tube Shenzhen Insighters Medical Technology Co., Ltd.


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