The following data is part of a premarket notification filed by Qualisys Ab with the FDA for Qualisys Clinical System.
| Device ID | K171547 |
| 510k Number | K171547 |
| Device Name: | Qualisys Clinical System |
| Classification | System, Optical Position/movement Recording |
| Applicant | Qualisys AB Kvarnbergsgatan 2 Goteborg, SE 411 05 |
| Contact | Henrik Wiberg |
| Correspondent | Nils Betzler Qualisys AB Kvarnbergsgatan 2 Goteborg, SE 411 05 |
| Product Code | LXJ |
| CFR Regulation Number | 890.5360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-26 |
| Decision Date | 2018-08-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07300009074518 | K171547 | 000 |