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FDA 510(k)

Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27)

N.º K: K243027 · 2025-04-08

SolicitanteHangzhou Sightnovo Medical Technology Co., Ltd.
Fecha de decisión2025-04-08
Código de productoQLY
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27) is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Sightnovo Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-04-08 under 510(k) number K243027. The device is classified under product code QLY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27)?

Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27) is a medical device that received FDA 510(k) clearance on 2025-04-08. The listed applicant is Hangzhou Sightnovo Medical Technology Co., Ltd.. The 510(k) number is K243027.

When did Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27) receive FDA 510(k) clearance?

Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27) received FDA 510(k) clearance on 2025-04-08, under 510(k) number K243027.

Who is the listed applicant for Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27)?

The FDA 510(k) record lists Hangzhou Sightnovo Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27)?

The FDA product code for Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27) is QLY.

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Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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