QbCheck

Recorder, Attention Task Performance

QBTECH AB

The following data is part of a premarket notification filed by Qbtech Ab with the FDA for Qbcheck.

Pre-market Notification Details

• Device ID: K143468
• 510k Number: K143468
• Device Name: QbCheck
• Classification: Recorder, Attention Task Performance
• Applicant: QBTECH AB Kungsgatan 29 Stockholm, SE 11156
• Contact: Hans Bostrom
• Correspondent: Hans Bostrom; QBTECH AB Kungsgatan 29 Stockholm, SE 11156
• Product Code: LQD
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-12-04
• Decision Date: 2016-03-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07350103930012	K143468	000