Zmachine

GUDID B5662000010

General Sleep

Electroencephalographic monitoring system, portable Electroencephalographic monitoring system, portable Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system

• Primary Device ID: B5662000010
• NIH Device Record Key: 0715c2ac-a894-4904-b57d-bd597a2598e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zmachine
• Version Model Number: Insight/Insight+
• Company DUNS: 860092022
• Company Name: General Sleep
• 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: true
• Manufacturing Date: true
• 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: (216) 289-2331
• Email: support@generalsleep.com
• Phone: (216) 289-2331
• Email: support@generalsleep.com
• Phone: (216) 289-2331
• Email: support@generalsleep.com
• Phone: (216) 289-2331
• Email: support@generalsleep.com
• Phone: (216) 289-2331
• Email: support@generalsleep.com
• Phone: (216) 289-2331
• Email: support@generalsleep.com
• Phone: (216) 289-2331
• Email: support@generalsleep.com
• Phone: (216) 289-2331
• Email: support@generalsleep.com
• Phone: (216) 289-2331
• Email: support@generalsleep.com
• Phone: (216) 289-2331
• Email: support@generalsleep.com
• Phone: (216) 289-2331
• Email: support@generalsleep.com
• Phone: (216) 289-2331
• Email: support@generalsleep.com
• Phone: (216) 289-2331
• Email: support@generalsleep.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B5662000010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142825

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-01-28
• Device Publish Date: 2018-12-27

On-Brand Devices [Zmachine]

• B5663000010: Synergy
• B5662000010: Insight/Insight+