SONON ULTRASOUND IMAGING SYSTEM

GUDID 08809489920005

Healcerion Co., Ltd.

General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system

• Primary Device ID: 08809489920005
• NIH Device Record Key: bdcb273d-c32c-4013-a817-fd26e61cb048
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SONON ULTRASOUND IMAGING SYSTEM
• Version Model Number: SONON 300C
• Company DUNS: 688732988
• Company Name: Healcerion 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: true
• Serial Number: true
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809489920005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151339

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: 2019-10-30
• Device Publish Date: 2019-10-22

On-Brand Devices [SONON ULTRASOUND IMAGING SYSTEM]

• 08809489920012: 300L
• 08809489920005: SONON 300C