明显数字视力产品
K号: K220090 · 2022-08-12
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决定日期2022-08-12
产品代码QTO
咨询委员会OP
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决定实质等同
器械摘要
Visibly Digital Acuity Product is the device name listed in this FDA 510(k) record. The listed applicant is Visibly, Inc.. It received FDA 510(k) clearance on 2022-08-12 under 510(k) number K220090. The device is classified under product code QTO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Visibly Digital Acuity Product?
Visibly Digital Acuity Product is a medical device that received FDA 510(k) clearance on 2022-08-12. The listed applicant is Visibly, Inc.. The 510(k) number is K220090.
When did Visibly Digital Acuity Product receive FDA 510(k) clearance?
Visibly Digital Acuity Product received FDA 510(k) clearance on 2022-08-12, under 510(k) number K220090.
Who is the listed applicant for Visibly Digital Acuity Product?
The FDA 510(k) record lists Visibly, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Visibly Digital Acuity Product?
The FDA product code for Visibly Digital Acuity Product is QTO.
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官方来源
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