FDA 510(k)

Laser Speckle Imaging System (RFLSI CZW)

N.º K: K233076 · 2024-05-28

Fecha de decisión2024-05-28

Código de productoDPT

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Laser Speckle Imaging System (RFLSI CZW) is the device name listed in this FDA 510(k) record. The listed applicant is Rwd Life Science Co., Ltd.. It received FDA 510(k) clearance on 2024-05-28 under 510(k) number K233076. The device is classified under product code DPT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Laser Speckle Imaging System (RFLSI CZW)?

Laser Speckle Imaging System (RFLSI CZW) is a medical device that received FDA 510(k) clearance on 2024-05-28. The listed applicant is Rwd Life Science Co., Ltd.. The 510(k) number is K233076.

When did Laser Speckle Imaging System (RFLSI CZW) receive FDA 510(k) clearance?

Laser Speckle Imaging System (RFLSI CZW) received FDA 510(k) clearance on 2024-05-28, under 510(k) number K233076.

Who is the listed applicant for Laser Speckle Imaging System (RFLSI CZW)?

The FDA 510(k) record lists Rwd Life Science Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Laser Speckle Imaging System (RFLSI CZW)?

The FDA product code for Laser Speckle Imaging System (RFLSI CZW) is DPT.

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Fuente oficial

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