睡眠呼吸暂停风险评估系统 (ARES)，型号 620
K号: K160499 · 2017-04-24
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决定日期2017-04-24
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
Apnea Risk Evaluation System (ARES), Model 620 is the device name listed in this FDA 510(k) record. The listed applicant is Watermark Medical. It received FDA 510(k) clearance on 2017-04-24 under 510(k) number K160499. 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 Apnea Risk Evaluation System (ARES), Model 620?
Apnea Risk Evaluation System (ARES), Model 620 is a medical device that received FDA 510(k) clearance on 2017-04-24. The listed applicant is Watermark Medical. The 510(k) number is K160499.
When did Apnea Risk Evaluation System (ARES), Model 620 receive FDA 510(k) clearance?
Apnea Risk Evaluation System (ARES), Model 620 received FDA 510(k) clearance on 2017-04-24, under 510(k) number K160499.
Who is the listed applicant for Apnea Risk Evaluation System (ARES), Model 620?
The FDA 510(k) record lists Watermark Medical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Apnea Risk Evaluation System (ARES), Model 620?
The FDA product code for Apnea Risk Evaluation System (ARES), Model 620 is MNR.
相关临床试验
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：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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