The following data is part of a premarket notification filed by Qbtech Ab with the FDA for Qbtes.
Device ID | K122149 |
510k Number | K122149 |
Device Name: | QBTES |
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 | 2012-07-19 |
Decision Date | 2012-10-17 |
Summary: | summary |