K254014

Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control

510(k) 号
K254014
器械名称
Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control
申请人
Stryker Endoscopy CA · US
产品代码
GCJ — Laparoscope, General & Plastic Surgery
批准日期
2026-01-13
受理日期
2025-12-15
决定
Substantially Equivalent
审查途径
Special
咨询委员会
Gastroenterology, Urology
510(k) Summary(FDA 官方 PDF): K254014.pdf
FDA 官方记录: K254014
数据来自 openFDA 510(k) 数据集(CC0 公有领域),以 FDA 现行记录为准。510(k) 许可不等于 FDA 认证或批准。