ME6000

GUDID 06430035220212

ME6000 is a portable telemetry and data logger in measurement and monitoring of electromyography (EMG) and other physiological signals.

Mega Elektroniikka Oy

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• Primary Device ID: 06430035220212
• NIH Device Record Key: 97938cea-a919-4cd2-aaf0-857627d67c2c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ME6000
• Version Model Number: ME6000 16ch
• Company DUNS: 369960000
• Company Name: Mega Elektroniikka Oy
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06430035220212 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K963202

FDA Product Code

• HCC: Device, Biofeedback

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: 2018-07-06
• Device Publish Date: 2016-09-22

On-Brand Devices [ME6000]

• 06430035220243: ME6000 is a portable telemetry and data logger in measurement and monitoring of electromyography
• 06430035220236: ME6000 is a portable telemetry and data logger in measurement and monitoring of electromyography
• 06430035220212: ME6000 is a portable telemetry and data logger in measurement and monitoring of electromyography
• 06430035220205: ME6000 is a portable telemetry and data logger in measurement and monitoring of electromyography
• 06430035220199: ME6000 is a portable telemetry and data logger in measurement and monitoring of electromyography