Luna® G3 BPAP 25A
K号: K201620 · 2021-01-29
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决定日期2021-01-29
产品代码BZD
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
Luna® G3 BPAP 25A is the device name listed in this FDA 510(k) record. The listed applicant is 3B Medical, Inc.. It received FDA 510(k) clearance on 2021-01-29 under 510(k) number K201620. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Luna® G3 BPAP 25A?
Luna® G3 BPAP 25A is a medical device that received FDA 510(k) clearance on 2021-01-29. The listed applicant is 3B Medical, Inc.. The 510(k) number is K201620.
When did Luna® G3 BPAP 25A receive FDA 510(k) clearance?
Luna® G3 BPAP 25A received FDA 510(k) clearance on 2021-01-29, under 510(k) number K201620.
Who is the listed applicant for Luna® G3 BPAP 25A?
The FDA 510(k) record lists 3B Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Luna® G3 BPAP 25A?
The FDA product code for Luna® G3 BPAP 25A is BZD.
列明3B Medical, Inc.为申报人的其他记录
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：BZD）
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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