SLM-1ER, SLM-2ER, SLM-3ER

FDA 510(k) K171877 · Chongqing Kanghua Ruiming S&T Co., Ltd.

Substantially Equivalent

510(k) numberK171877

Submission

Device name
SLM-1ER, SLM-2ER, SLM-3ER
Applicant
Chongqing Kanghua Ruiming S&T Co., Ltd.
Chongqing, CN
Received
June 23, 2017
Decision date
December 21, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HJO – Biomicroscope, Slit-Lamp, Ac-Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 886.1850
Specialty
Ophthalmic

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K182306Sunkingdom Slit LampHJO · Traditional Chongqing Sunkingdom Medical Instrument Co., Ltd.11/22/2018SE
K173771IOLMaster 700HJO · Traditional Carl Zeiss Meditec, AG08/24/2018SE
K170470Digital Eye Anterior CameraHJO · Traditional Medimaging Integrated Solution, Inc (Miis)10/06/2017SE
K162778Portable Slit Lamp MicroscopeHJO · Traditional Suzhou Kangjie Medical, Inc.07/21/2017SE
K162684SL 220HJO · Traditional Carl Zeiss Meditec, AG05/31/2017SE
K163564Slit Lamp SL-2000HJO · Traditional Nidek Co., Ltd.05/19/2017SE

Questions and answers

When was SLM-1ER, SLM-2ER, SLM-3ER cleared by the FDA?

SLM-1ER, SLM-2ER, SLM-3ER (K171877) received a 510(k) decision of Substantially Equivalent on December 21, 2017, 181 days after the submission was received.

What is the product code of K171877?

The FDA product code is HJO – Biomicroscope, Slit-Lamp, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1850.