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：P130007 · 2018-07-11
广告
申请人Animas Corp.
决定日期2018-07-11
PMA 编号P130007
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 Animas Corp.. It received FDA 510(k) clearance on 2018-07-11. 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 2018-07-11. The listed applicant is Animas Corp..
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 Animas Corp. 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.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
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。
广告