iTEAR100 神经刺激器
K号: K213623 · 2022-03-16
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决定日期2022-03-16
产品代码QKV
咨询委员会OP
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决定实质等同
器械摘要
iTEAR100 Neurostimulator is the device name listed in this FDA 510(k) record. The listed applicant is Olympic Ophthalmics. It received FDA 510(k) clearance on 2022-03-16 under 510(k) number K213623. The device is classified under product code QKV. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the iTEAR100 Neurostimulator?
iTEAR100 Neurostimulator is a medical device that received FDA 510(k) clearance on 2022-03-16. The listed applicant is Olympic Ophthalmics. The 510(k) number is K213623.
When did iTEAR100 Neurostimulator receive FDA 510(k) clearance?
iTEAR100 Neurostimulator received FDA 510(k) clearance on 2022-03-16, under 510(k) number K213623.
Who is the listed applicant for iTEAR100 Neurostimulator?
The FDA 510(k) record lists Olympic Ophthalmics as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for iTEAR100 Neurostimulator?
The FDA product code for iTEAR100 Neurostimulator is QKV.
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官方来源
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