AUDICOR CA300/CC100分析仪，配备SDB
K号: K151433 · 2016-03-18
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决定日期2016-03-18
产品代码MNR
咨询委员会AN
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决定实质等同
器械摘要
AUDICOR CA300/CC100 Analyzer with SDB is the device name listed in this FDA 510(k) record. The listed applicant is Inovise Medical, Inc.. It received FDA 510(k) clearance on 2016-03-18 under 510(k) number K151433. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the AUDICOR CA300/CC100 Analyzer with SDB?
AUDICOR CA300/CC100 Analyzer with SDB is a medical device that received FDA 510(k) clearance on 2016-03-18. The listed applicant is Inovise Medical, Inc.. The 510(k) number is K151433.
When did AUDICOR CA300/CC100 Analyzer with SDB receive FDA 510(k) clearance?
AUDICOR CA300/CC100 Analyzer with SDB received FDA 510(k) clearance on 2016-03-18, under 510(k) number K151433.
Who is the listed applicant for AUDICOR CA300/CC100 Analyzer with SDB?
The FDA 510(k) record lists Inovise Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AUDICOR CA300/CC100 Analyzer with SDB?
The FDA product code for AUDICOR CA300/CC100 Analyzer with SDB is MNR.
相关临床试验
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相关器械（代码：MNR）
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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