Parkell 感觉丧失凝胶
K号: K191103 · 2019-11-22
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决定日期2019-11-22
产品代码EJK
咨询委员会DE
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决定实质等同
器械摘要
Parkell Desensitizer Gel is the device name listed in this FDA 510(k) record. The listed applicant is Parkell, Inc.. It received FDA 510(k) clearance on 2019-11-22 under 510(k) number K191103. The device is classified under product code EJK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Parkell Desensitizer Gel?
Parkell Desensitizer Gel is a medical device that received FDA 510(k) clearance on 2019-11-22. The listed applicant is Parkell, Inc.. The 510(k) number is K191103.
When did Parkell Desensitizer Gel receive FDA 510(k) clearance?
Parkell Desensitizer Gel received FDA 510(k) clearance on 2019-11-22, under 510(k) number K191103.
Who is the listed applicant for Parkell Desensitizer Gel?
The FDA 510(k) record lists Parkell, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Parkell Desensitizer Gel?
The FDA product code for Parkell Desensitizer Gel is EJK.
相关临床试验
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列明Parkell, 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：EJK）
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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