Tristel OPH
K号: K242732 · 2025-05-09
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决定日期2025-05-09
产品代码QWS
咨询委员会医疗设备监管文本翻译如下：
HO
请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同
器械摘要
Tristel OPH is the device name listed in this FDA 510(k) record. The listed applicant is Tristel Solutions , Ltd.. It received FDA 510(k) clearance on 2025-05-09 under 510(k) number K242732. The device is classified under product code QWS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Tristel OPH?
Tristel OPH is a medical device that received FDA 510(k) clearance on 2025-05-09. The listed applicant is Tristel Solutions , Ltd.. The 510(k) number is K242732.
When did Tristel OPH receive FDA 510(k) clearance?
Tristel OPH received FDA 510(k) clearance on 2025-05-09, under 510(k) number K242732.
Who is the listed applicant for Tristel OPH?
The FDA 510(k) record lists Tristel Solutions , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Tristel OPH?
The FDA product code for Tristel OPH is QWS.
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官方来源
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