The following data is part of a premarket notification filed by Quantified Signal Imaging, Inc. with the FDA for Qsi 9000.
| Device ID | K894560 |
| 510k Number | K894560 |
| Device Name: | QSI 9000 |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | QUANTIFIED SIGNAL IMAGING, INC. 290 YORKLAND BLVD. Toronto, CA M2j 1r5 |
| Contact | Kalnay, C.a. |
| Correspondent | Kalnay, C.a. QUANTIFIED SIGNAL IMAGING, INC. 290 YORKLAND BLVD. Toronto, CA M2j 1r5 |
| Product Code | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-20 |
| Decision Date | 1990-08-08 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() QSI 9000 73671132 1514490 Dead/Cancelled |
QUANTIFIED SIGNAL IMAGING INC. 1987-07-10 |