Digital Color Doppler Palm Ultrasound System

GUDID 06945121413091

CHISON Medical Technologies Co., Ltd.

General-purpose ultrasound imaging system

• Primary Device ID: 06945121413091
• NIH Device Record Key: f0851095-b4ca-4329-a2ec-57fde1d16bdd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Digital Color Doppler Palm Ultrasound System
• Version Model Number: SonoEye P5
• Company DUNS: 544914187
• Company Name: CHISON Medical Technologies 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: 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	06945121413091 [Primary]
GS1	06945121413138 [Package]; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201971

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

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: 2021-03-12
• Device Publish Date: 2021-03-04

On-Brand Devices [Digital Color Doppler Palm Ultrasound System]

• 06945121413091: SonoEye P5
• 06945121413084: SonoEye P3
• 06945121413077: SonoEye P2
• 06945121413060: SonoEye P1
• 06945121413183: SonoEye P6
• 06945121413688: SonoEye G5
• 06945121413671: SonoEye G2
• 06945121415194: SonoEye G6