QbCheck

GUDID 07350103930012

Qbtech AB

Psychological assessment software Psychological assessment software Psychological assessment software Psychological assessment software Psychological assessment software Psychological assessment software Psychological assessment software Psychological assessment software Psychological assessment software Psychological assessment software Psychological assessment software Psychological assessment software Psychological assessment software Psychological assessment software Psychological assessment software Psychological assessment software

• Primary Device ID: 07350103930012
• NIH Device Record Key: 40f60cf3-a80a-43be-a22f-a7dd7fc73f9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QbCheck
• Version Model Number: 001
• Company DUNS: 508374720
• Company Name: Qbtech AB
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350103930012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143468

FDA Product Code

• LQD: Recorder, Attention Task Performance

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: 2023-06-22
• Device Publish Date: 2023-06-14

Devices Manufactured by Qbtech AB

• 07350103930012 - QbCheck: 2023-06-22
• 07350103930012 - QbCheck: 2023-06-22
• 07350103930067 - QbTest: 2023-06-22