QSI 9500

Normalizing Quantitative Electroencephalograph Software

QUANTIFIED SIGNAL IMAGING, INC.

The following data is part of a premarket notification filed by Quantified Signal Imaging, Inc. with the FDA for Qsi 9500.

Pre-market Notification Details

• Device ID: K904294
• 510k Number: K904294
• Device Name: QSI 9500
• Classification: Normalizing Quantitative Electroencephalograph Software
• Applicant: QUANTIFIED SIGNAL IMAGING, INC. 290 YORKLAND BLVD. Toronto, CA M2j 1r5
• Contact: Howard Galin
• Correspondent: Howard Galin; QUANTIFIED SIGNAL IMAGING, INC. 290 YORKLAND BLVD. Toronto, CA M2j 1r5
• Product Code: OLU
• Subsequent Product Code: GWE
• Subsequent Product Code: GWF
• Subsequent Product Code: GWJ
• CFR Regulation Number: 882.1400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-09-19
• Decision Date: 1991-07-30