eego amplifier

GUDID B195EE212

physiological signal amplfier

eemagine Medical Imaging Solutions GmbH

Electroencephalographic signal amplifier

• Primary Device ID: B195EE212
• NIH Device Record Key: 70d2c000-a7d1-4e36-a790-a819455411e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: eego amplifier
• Version Model Number: EE-212
• Company DUNS: 313152485
• Company Name: eemagine Medical Imaging Solutions GmbH
• 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: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B195EE212 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172312

FDA Product Code

• GWL: AMPLIFIER, PHYSIOLOGICAL SIGNAL

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-07

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• B195EE213: physiological signal amplfier
• B195EE212: physiological signal amplfier
• B195EE211: physiological signal amplfier
• B195EE410: StimGuide component
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