Falck 医疗多功能眼压计，FAT1
K号: K151491 · 2016-01-15
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决定日期2016-01-15
产品代码HKY
咨询委员会OP
请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。
决定实质等同
器械摘要
Falck Medical Multifunction Tonometer, FAT1 is the device name listed in this FDA 510(k) record. The listed applicant is Falck Medical, Inc.. It received FDA 510(k) clearance on 2016-01-15 under 510(k) number K151491. The device is classified under product code HKY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Falck Medical Multifunction Tonometer, FAT1?
Falck Medical Multifunction Tonometer, FAT1 is a medical device that received FDA 510(k) clearance on 2016-01-15. The listed applicant is Falck Medical, Inc.. The 510(k) number is K151491.
When did Falck Medical Multifunction Tonometer, FAT1 receive FDA 510(k) clearance?
Falck Medical Multifunction Tonometer, FAT1 received FDA 510(k) clearance on 2016-01-15, under 510(k) number K151491.
Who is the listed applicant for Falck Medical Multifunction Tonometer, FAT1?
The FDA 510(k) record lists Falck Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Falck Medical Multifunction Tonometer, FAT1?
The FDA product code for Falck Medical Multifunction Tonometer, FAT1 is HKY.
相关临床试验
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相关器械（代码：HKY）
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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