SML-OSA2 设备
K号: K162816 · 2017-07-27
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决定日期2017-07-27
产品代码LQZ
咨询委员会DE
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决定实质等同
器械摘要
SML-OSA2 Appliances is the device name listed in this FDA 510(k) record. The listed applicant is Selane Products, Inc.. It received FDA 510(k) clearance on 2017-07-27 under 510(k) number K162816. The device is classified under product code LQZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SML-OSA2 Appliances?
SML-OSA2 Appliances is a medical device that received FDA 510(k) clearance on 2017-07-27. The listed applicant is Selane Products, Inc.. The 510(k) number is K162816.
When did SML-OSA2 Appliances receive FDA 510(k) clearance?
SML-OSA2 Appliances received FDA 510(k) clearance on 2017-07-27, under 510(k) number K162816.
Who is the listed applicant for SML-OSA2 Appliances?
The FDA 510(k) record lists Selane Products, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SML-OSA2 Appliances?
The FDA product code for SML-OSA2 Appliances is LQZ.
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相关器械（代码：LQZ）
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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