Aquarius 8600 数字X光传感器
K号: K181565 · 2018-07-13
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器械摘要
Aquarius 8600 Digital Radiography Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Biokinemetrics, Inc.. It received FDA 510(k) clearance on 2018-07-13 under 510(k) number K181565. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Aquarius 8600 Digital Radiography Sensor?
Aquarius 8600 Digital Radiography Sensor is a medical device that received FDA 510(k) clearance on 2018-07-13. The listed applicant is Biokinemetrics, Inc.. The 510(k) number is K181565.
When did Aquarius 8600 Digital Radiography Sensor receive FDA 510(k) clearance?
Aquarius 8600 Digital Radiography Sensor received FDA 510(k) clearance on 2018-07-13, under 510(k) number K181565.
Who is the listed applicant for Aquarius 8600 Digital Radiography Sensor?
The FDA 510(k) record lists Biokinemetrics, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Aquarius 8600 Digital Radiography Sensor?
The FDA product code for Aquarius 8600 Digital Radiography Sensor is MQB.
相关临床试验
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列明Biokinemetrics, 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：MQB）
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。
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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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