GUDID 06951214400022

The KH Ophthalmic Slit-lamp Microscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's

Chongqing Kanghuaruiming S&T Co., Ltd..

Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination
Primary Device ID06951214400022
NIH Device Record Key59ad39ce-588a-4cff-ba81-0a7d21347769
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberSLM-2ER
Company DUNS543066376
Company NameChongqing Kanghuaruiming S&T Co., Ltd..
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106951214400022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HJOBiomicroscope, Slit-Lamp, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-03-21

Devices Manufactured by Chongqing Kanghuaruiming S&T Co., Ltd..

06951214400015 - NA2018-07-06
06951214400022 - NA2018-07-06The KH Ophthalmic Slit-lamp Microscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's
06951214400022 - NA2018-07-06 The KH Ophthalmic Slit-lamp Microscope is an AC-powered device that is a microscope intended for use in eye examination that pro
06951214400039 - NA2018-07-06 The KH Ophthalmic Slit-lamp Microscope is an AC-powered device that is a microscope intended for use in eye examination that pro
06951214400077 - NA2018-04-23 This device is used to create digital colour photographic images of the ocular fundus through the pupil, to aid in diagnosing an
06951214400084 - NA2018-04-23 This system adopts the most advanced Optical-electro-mechanical Integration technology. It integrates digital Fundus-Fluorescein
06951214400091 - NA2018-04-23 The projection perimeters is used to check the sensitivity of the human eye to light(visual acuity). Ambient light by refractio
06951214400107 - NA2018-04-23 The projection perimeters is used to check the sensitivity of the human eye to light(visual acuity). Ambient light by refractio
06951214400213 - NA2018-04-23 This system adopts the most advanced Optical-electro-mechanical Integration technology. It integrates digital Fundus-Fluorescein
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