FDA 510(k)

Portable Slit Lamp

Número K: K153545 · 2016-06-22

RequerenteShanghai Bolan Optical-Electric Co., Ltd.

Data da decisão2016-06-22

Código do produtoHJO

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

Portable Slit Lamp is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Bolan Optical-Electric Co., Ltd.. It received FDA 510(k) clearance on 2016-06-22 under 510(k) number K153545. 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?

Portable Slit Lamp is a medical device that received FDA 510(k) clearance on 2016-06-22. The listed applicant is Shanghai Bolan Optical-Electric Co., Ltd.. The 510(k) number is K153545.

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

Portable Slit Lamp received FDA 510(k) clearance on 2016-06-22, under 510(k) number K153545.

Who is the listed applicant for Portable Slit Lamp?

The FDA 510(k) record lists Shanghai Bolan Optical-Electric Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Portable Slit Lamp?

The FDA product code for Portable Slit Lamp is HJO.

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