GUDID 06951214400039

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

• Primary Device ID: 06951214400039
• NIH Device Record Key: 807bc588-dce3-48dc-99af-e77460c6be2f
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: SLM-3ER
• Company DUNS: 543066376
• Company Name: Chongqing Kanghuaruiming S&T Co., Ltd..
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06951214400039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171877

FDA Product Code

• HJO: Biomicroscope, Slit-Lamp, Ac-Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-22

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

• 06951214400015 - NA: 2018-07-06
• 06951214400022 - NA: 2018-07-06 The KH Ophthalmic Slit-lamp Microscope is an AC-powered device that is a microscope intended for use in eye examination that pro
• 06951214400039 - NA: 2018-07-06The 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
• 06951214400039 - NA: 2018-07-06 The KH Ophthalmic Slit-lamp Microscope is an AC-powered device that is a microscope intended for use in eye examination that pro
• 06951214400077 - NA: 2018-04-23 This device is used to create digital colour photographic images of the ocular fundus through the pupil, to aid in diagnosing an
• 06951214400084 - NA: 2018-04-23 This system adopts the most advanced Optical-electro-mechanical Integration technology. It integrates digital Fundus-Fluorescein
• 06951214400091 - NA: 2018-04-23 The projection perimeters is used to check the sensitivity of the human eye to light(visual acuity). Ambient light by refractio
• 06951214400107 - NA: 2018-04-23 The projection perimeters is used to check the sensitivity of the human eye to light(visual acuity). Ambient light by refractio
• 06951214400213 - NA: 2018-04-23 This system adopts the most advanced Optical-electro-mechanical Integration technology. It integrates digital Fundus-Fluorescein