Faros 360 waterproof 901159

GUDID 06430035220311

Device for 3-channel ECG and motion measurement, monitoring and data collection.

Mega Elektroniikka Oy

Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder

• Primary Device ID: 06430035220311
• NIH Device Record Key: 49e70c85-1f91-4687-88e7-a5ce1e144ebd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Faros 360 waterproof
• Version Model Number: Faros 360
• Catalog Number: 901159
• 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: medical.support@bittium.com
• Phone: +358175817700
• Email: medical.support@bittium.com
• Phone: +358175817700
• Email: medical.support@bittium.com
• Phone: +358175817700
• Email: medical.support@bittium.com
• Phone: +358175817700
• Email: medical.support@bittium.com
• Phone: +358175817700
• Email: medical.support@bittium.com
• Phone: +358175817700
• Email: medical.support@bittium.com
• Phone: +358175817700
• Email: medical.support@bittium.com
• Phone: +358175817700
• Email: medical.support@bittium.com
• Phone: +358175817700
• Email: medical.support@bittium.com
• Phone: +358175817700
• Email: medical.support@bittium.com
• Phone: +358175817700
• Email: medical.support@bittium.com
• Phone: +358175817700
• Email: medical.support@bittium.com
• Phone: +358175817700
• Email: medical.support@bittium.com
• Phone: +358175817700
• Email: medical.support@bittium.com
• Phone: +358175817700
• Email: medical.support@bittium.com
• Phone: +358175817700
• Email: medical.support@bittium.com
• Phone: +358175817700
• Email: medical.support@bittium.com
• Phone: +358175817700
• Email: medical.support@bittium.com
• Phone: +358175817700
• Email: medical.support@bittium.com
• Phone: +358175817700
• Email: medical.support@bittium.com
• Phone: +358175817700
• Email: medical.support@bittium.com
• Phone: +358175817700
• Email: medical.support@bittium.com
• Phone: +358175817700
• Email: medical.support@bittium.com
• Phone: +358175817700
• Email: medical.support@bittium.com
• Phone: +358175817700
• Email: medical.support@bittium.com
• Phone: +358175817700
• Email: medical.support@bittium.com
• Phone: +358175817700
• Email: medical.support@bittium.com
• Phone: +358175817700
• Email: medical.support@bittium.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	06430035220311 [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: 3
• Public Version Date: 2019-11-08
• Device Publish Date: 2018-04-30

Devices Manufactured by Mega Elektroniikka Oy

• 06430035220366 - Bittium Faros: 2019-11-08 Device for 3-channel ECG and motion measurement, monitoring and data collection
• 06430035220311 - Faros 360 waterproof: 2019-11-08Device for 3-channel ECG and motion measurement, monitoring and data collection.
• 06430035220311 - Faros 360 waterproof: 2019-11-08 Device for 3-channel ECG and motion measurement, monitoring and data collection.
• 06430035220335 - Fast-Fix ECG Electrode: 2018-08-06 The Fast-Fix ECG Electrode is a user-friendly, single-use electrode meant to use with Faros ECG devices. The electrode is affixe
• 06430035220014 - FemiScan: 2018-07-06 FemiScan device is for monitoring and recording muscle activity of the pelvic floor muscles by using EMG-signals.
• 06430035220021 - FemiScan: 2018-07-06 Electrode for FemiScan HomeTrainer (HTCS) device. For single patient use.
• 06430035220151 - Faros: 2018-07-06 Device for 1-channel ECG and motion measurement and data collection
• 06430035220168 - Faros: 2018-07-06 Device for 1-channel ECG and motion measurement, monitoring and data collection
• 06430035220175 - Faros: 2018-07-06 Device for 3-channel ECG and motion measurement, monitoring and data collection