e-SDF
K号: K240619 · 2024-03-06
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决定日期2024-03-06
产品代码PHR
咨询委员会DE
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决定实质等同
器械摘要
e-SDF is the device name listed in this FDA 510(k) record. The listed applicant is Kids-E-Dental Llp. It received FDA 510(k) clearance on 2024-03-06 under 510(k) number K240619. The device is classified under product code PHR. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the e-SDF?
e-SDF is a medical device that received FDA 510(k) clearance on 2024-03-06. The listed applicant is Kids-E-Dental Llp. The 510(k) number is K240619.
When did e-SDF receive FDA 510(k) clearance?
e-SDF received FDA 510(k) clearance on 2024-03-06, under 510(k) number K240619.
Who is the listed applicant for e-SDF?
The FDA 510(k) record lists Kids-E-Dental Llp as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for e-SDF?
The FDA product code for e-SDF is PHR.
相关器械（代码：PHR）
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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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