The following data is part of a premarket notification filed by Quantified Signal Imaging, Inc. with the FDA for Quantimap Iii.
| Device ID | K863650 |
| 510k Number | K863650 |
| Device Name: | QUANTIMAP III |
| Classification | Non-normalizing Quantitative Electroencephalograph Software |
| Applicant | QUANTIFIED SIGNAL IMAGING, INC. 290 YORKLAND BLVD. Toronto, CA M2j 1r5 |
| Contact | Michael J Cannata |
| Correspondent | Michael J Cannata QUANTIFIED SIGNAL IMAGING, INC. 290 YORKLAND BLVD. Toronto, CA M2j 1r5 |
| Product Code | OLT |
| Subsequent Product Code | GWE |
| Subsequent Product Code | GWF |
| Subsequent Product Code | GWJ |
| Subsequent Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-18 |
| Decision Date | 1986-09-26 |