Sensor, glucose, invasive，非辅助性，工厂校准，用户启动
PMA编号：P160030 · 2026-09-01
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决定日期2026-09-01
PMA 编号P160030
产品代码PZE
设备分类第3类
医疗专科U
咨询委员会CH
请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
器械摘要
Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Diabetes Care, Inc.. It received FDA 510(k) clearance on 2026-09-01. The device is classified under product code PZE. It was reviewed by the CH advisory panel.
常见问题
What is the Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated?
Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated is a medical device that received FDA 510(k) clearance on 2026-09-01. The listed applicant is Abbott Diabetes Care, Inc..
When did Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated receive FDA 510(k) clearance?
The clearance date for Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated can be found in the official FDA records.
Sensor,葡萄糖，侵入式，非辅助性，工厂校准，用户启动的申请人是谁？
The FDA 510(k) record lists Abbott Diabetes Care, Inc. as the applicant. This does not by itself establish the device manufacturer.
什么是Sensor，葡萄糖，侵入性，非辅助性，工厂校准，用户启动的FDA产品代码？
FDA产品代码为Sensor、葡萄糖、侵入性、非辅助性、工厂校准、用户启动的是PZE。
相关临床试验
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官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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