QbCheck

Basic Information

• Brand Name: QbCheck
• Primary DI: 07350103930012
• Version / Model: 001
• Company Name: Qbtech AB
• Labeler DUNS: 508374720
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-14
• Public Version: 1
• Public Version Date: 2023-06-22
• Public Version Status: New
• Public Device Record Key: 40f60cf3-a80a-43be-a22f-a7dd7fc73f9d

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LQD	Recorder, Attention Task Performance	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
58290	Psychological assessment software	A screen-based (non-virtual-reality) software program intended to be used by patients and medical professionals to evaluate and determine the psychological profile of the patient; it may in addition be used to monitor the effectiveness and progress of psychotherapy, however it is not primarily intended to provide interactive therapy. It typically uses psychological tests/questionnaires and patient demographics (e.g., smartphone digital phenotype) to establish a mental wellbeing score, and may also provide resources to promote patient awareness and recovery.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07350103930012	GS1

Premarket Submissions

Submission Number	Supplement Number
K143468	000