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 |