SancDam 橡胶口咽隔膜
K号: K212037 · 2022-03-28
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决定日期2022-03-28
产品代码MSC
咨询委员会OB
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
SancDam Latex Oral Dam is the device name listed in this FDA 510(k) record. The listed applicant is Sanctuary Health Sdn. Bhd.. It received FDA 510(k) clearance on 2022-03-28 under 510(k) number K212037. The device is classified under product code MSC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SancDam Latex Oral Dam?
SancDam Latex Oral Dam is a medical device that received FDA 510(k) clearance on 2022-03-28. The listed applicant is Sanctuary Health Sdn. Bhd.. The 510(k) number is K212037.
When did SancDam Latex Oral Dam receive FDA 510(k) clearance?
SancDam Latex Oral Dam received FDA 510(k) clearance on 2022-03-28, under 510(k) number K212037.
Who is the listed applicant for SancDam Latex Oral Dam?
The FDA 510(k) record lists Sanctuary Health Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SancDam Latex Oral Dam?
The FDA product code for SancDam Latex Oral Dam is MSC.
相关临床试验
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相关器械（代码：MSC）
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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