Live View Panel Version 1.3

GUDID 00817111020786

Live View Panel Version 1.3

NEUROTRONICS, INC.

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• Primary Device ID: 00817111020786
• NIH Device Record Key: ca2333e4-44cb-4dd4-af3d-39862c6bce9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Live View Panel Version 1.3
• Version Model Number: 1.3
• Company DUNS: 036405363
• Company Name: NEUROTRONICS, INC.
• 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: false
• 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	00817111020786 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131415

FDA Product Code

• OLZ: Automatic Event Detection Software For Polysomnograph With Electroencephalograph

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-12-11
• Device Publish Date: 2016-09-22

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