电磁肌刺激疗法作为预防PICC导管相关血栓形成的预防方法
K号: K222496 · 2022-11-18
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决定日期2022-11-18
产品代码BYI
咨询委员会AN
请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。
决定实质等同
器械摘要
Electromed SmartVest Airway Clearance System is the device name listed in this FDA 510(k) record. The listed applicant is Electromed, Inc.. It received FDA 510(k) clearance on 2022-11-18 under 510(k) number K222496. The device is classified under product code BYI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Electromed SmartVest Airway Clearance System?
Electromed SmartVest Airway Clearance System is a medical device that received FDA 510(k) clearance on 2022-11-18. The listed applicant is Electromed, Inc.. The 510(k) number is K222496.
When did Electromed SmartVest Airway Clearance System receive FDA 510(k) clearance?
Electromed SmartVest Airway Clearance System received FDA 510(k) clearance on 2022-11-18, under 510(k) number K222496.
Who is the listed applicant for Electromed SmartVest Airway Clearance System?
The FDA 510(k) record lists Electromed, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Electromed SmartVest Airway Clearance System?
The FDA product code for Electromed SmartVest Airway Clearance System is BYI.
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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。
相关器械（代码：BYI）
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。
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