EasyOne Air Spirometer
K号: K161536 · 2017-01-05
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决定日期2017-01-05
产品代码BZG
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。
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器械摘要
EasyOne Air Spirometer is the device name listed in this FDA 510(k) record. The listed applicant is Ndd Medizintechnik AG. It received FDA 510(k) clearance on 2017-01-05 under 510(k) number K161536. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the EasyOne Air Spirometer?
EasyOne Air Spirometer is a medical device that received FDA 510(k) clearance on 2017-01-05. The listed applicant is Ndd Medizintechnik AG. The 510(k) number is K161536.
When did EasyOne Air Spirometer receive FDA 510(k) clearance?
EasyOne Air Spirometer received FDA 510(k) clearance on 2017-01-05, under 510(k) number K161536.
Who is the listed applicant for EasyOne Air Spirometer?
The FDA 510(k) record lists Ndd Medizintechnik AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EasyOne Air Spirometer?
The FDA product code for EasyOne Air Spirometer is BZG.
相关临床试验
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列明Ndd Medizintechnik AG为申报人的其他记录
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相关器械（代码：BZG）
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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