FDA 510(k)

Portable Slit Lamp Microscope

Número K: K162778 · 2017-07-21

Data da decisão2017-07-21

Código do produtoHJO

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

Portable Slit Lamp Microscope is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Kangjie Medical, Inc.. It received FDA 510(k) clearance on 2017-07-21 under 510(k) number K162778. The device is classified under product code HJO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Portable Slit Lamp Microscope?

Portable Slit Lamp Microscope is a medical device that received FDA 510(k) clearance on 2017-07-21. The listed applicant is Suzhou Kangjie Medical, Inc.. The 510(k) number is K162778.

When did Portable Slit Lamp Microscope receive FDA 510(k) clearance?

Portable Slit Lamp Microscope received FDA 510(k) clearance on 2017-07-21, under 510(k) number K162778.

Who is the listed applicant for Portable Slit Lamp Microscope?

The FDA 510(k) record lists Suzhou Kangjie Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Portable Slit Lamp Microscope?

The FDA product code for Portable Slit Lamp Microscope is HJO.

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