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Shenzhen Insighters Medical Technology Co., Ltd.

FDA 510(k) & PMA Approved Devices — 3 products

Total Devices3
Categories2
Latest Approval2025-05-28
TypeNumberDevice NameCodeDate
510(k) K242793 Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; Insighters™ Insight Workstation iS-PF1. EOQ 2025-05-28 View
510(k) K232529 Disposable Double Lumen Endobronchial Tube CBI 2024-05-13 View
510(k) K232580 Disposable Endobronchial Blocker Tube CBI 2023-12-14 View