Faros

GUDID 06430035220168

Device for 1-channel ECG and motion measurement, monitoring and data collection

Mega Elektroniikka Oy

Electrocardiograph, professional, single-channel Electrocardiograph, professional, single-channel Electrocardiograph, professional, single-channel Electrocardiograph, professional, single-channel Electrocardiograph, professional, single-channel Electrocardiograph, professional, single-channel Electrocardiograph, professional, single-channel Electrocardiograph, professional, single-channel Electrocardiograph, professional, single-channel Electrocardiograph, professional, single-channel Electrocardiograph, professional, single-channel Electrocardiograph, professional, single-channel Electrocardiograph, professional, single-channel Electrocardiograph, professional, single-channel Electrocardiograph, professional, single-channel Electrocardiograph, professional, single-channel Electrocardiograph, professional, single-channel Electrocardiograph, professional, single-channel Electrocardiograph, professional, single-channel Electrocardiograph, professional, single-channel Electrocardiograph, professional, single-channel Electrocardiograph, professional, single-channel Electrocardiograph, professional, single-channel Electrocardiograph, professional, single-channel

• Primary Device ID: 06430035220168
• NIH Device Record Key: 91d09f0c-d5ac-40d4-bc2f-56835679d426
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Faros
• Version Model Number: Faros 180
• Company DUNS: 369960000
• Company Name: Mega Elektroniikka Oy
• 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: 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: +358175817700
• Email: mega@megaemg.com
• Phone: +358175817700
• Email: mega@megaemg.com
• Phone: +358175817700
• Email: mega@megaemg.com
• Phone: +358175817700
• Email: mega@megaemg.com
• Phone: +358175817700
• Email: mega@megaemg.com
• Phone: +358175817700
• Email: mega@megaemg.com
• Phone: +358175817700
• Email: mega@megaemg.com
• Phone: +358175817700
• Email: mega@megaemg.com
• Phone: +358175817700
• Email: mega@megaemg.com
• Phone: +358175817700
• Email: mega@megaemg.com
• Phone: +358175817700
• Email: mega@megaemg.com
• Phone: +358175817700
• Email: mega@megaemg.com
• Phone: +358175817700
• Email: mega@megaemg.com
• Phone: +358175817700
• Email: mega@megaemg.com
• Phone: +358175817700
• Email: mega@megaemg.com
• Phone: +358175817700
• Email: mega@megaemg.com
• Phone: +358175817700
• Email: mega@megaemg.com
• Phone: +358175817700
• Email: mega@megaemg.com
• Phone: +358175817700
• Email: mega@megaemg.com
• Phone: +358175817700
• Email: mega@megaemg.com
• Phone: +358175817700
• Email: mega@megaemg.com
• Phone: +358175817700
• Email: mega@megaemg.com
• Phone: +358175817700
• Email: mega@megaemg.com
• Phone: +358175817700
• Email: mega@megaemg.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	06430035220168 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143032

FDA Product Code

• DXH: Transmitters And Receivers, Electrocardiograph, Telephone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

On-Brand Devices [Faros]

• 06430035220175: Device for 3-channel ECG and motion measurement, monitoring and data collection
• 06430035220168: Device for 1-channel ECG and motion measurement, monitoring and data collection
• 06430035220151: Device for 1-channel ECG and motion measurement and data collection