用于与侵入性葡萄糖传感器一起使用的胰岛素输注泵
PMA编号：P140015 · 2019-12-19
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决定日期2019-12-19
PMA 编号P140015
产品代码OYC
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
Pump, infusion, insulin, to be used with invasive glucose sensor is the device name listed in this FDA 510(k) record. The listed applicant is Tandem Diabetes Care, Inc.. It received FDA 510(k) clearance on 2019-12-19. The device is classified under product code OYC. It was reviewed by the CH advisory panel.
常见问题
What is the Pump, infusion, insulin, to be used with invasive glucose sensor?
Pump, infusion, insulin, to be used with invasive glucose sensor is a medical device that received FDA 510(k) clearance on 2019-12-19. The listed applicant is Tandem Diabetes Care, Inc..
When did Pump, infusion, insulin, to be used with invasive glucose sensor receive FDA 510(k) clearance?
The clearance date for Pump, infusion, insulin, to be used with invasive glucose sensor can be found in the official FDA records.
Who is the listed applicant for Pump, infusion, insulin, to be used with invasive glucose sensor?
The FDA 510(k) record lists Tandem Diabetes Care, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Pump, infusion, insulin, to be used with invasive glucose sensor?
The FDA product code for Pump, infusion, insulin, to be used with invasive glucose sensor is OYC.
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官方来源
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