Eview

GUDID 06971176280135

This equipment has been designed to be used to process signals from an endoscope and convert it to a signal that can be displayed on the monitor.

Zhuhai Pusen Medical Technology Co, Ltd

Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit

• Primary Device ID: 06971176280135
• NIH Device Record Key: 2f4c6459-ee1e-4edf-8d78-795d3352f8b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eview
• Version Model Number: PV220
• Company DUNS: 544427443
• Company Name: Zhuhai Pusen Medical Technology Co, Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: false
• 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	06971176280135 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190648

FDA Product Code

• FET: Endoscopic Video Imaging System/Component, Gastroenterology-Urology

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-24
• Device Publish Date: 2021-03-16

On-Brand Devices [Eview]

• 16971176280002: This instrument has been designed to be used with endo-therapy accessories such as a biopsy forc
• 06971176280043: This equipment has been designed to be used to process signals from an endoscope and convert it
• 06971176280135: This equipment has been designed to be used to process signals from an endoscope and convert it
• 06971176280241: This instrument has been designed to be used to process signals from a video endoscope and conve