LUNA

Non-normalizing Quantitative Electroencephalograph Software

STELLATE SYSTEMS

The following data is part of a premarket notification filed by Stellate Systems with the FDA for Luna.

Pre-market Notification Details

• Device ID: K982351
• 510k Number: K982351
• Device Name: LUNA
• Classification: Non-normalizing Quantitative Electroencephalograph Software
• Applicant: STELLATE SYSTEMS 345 VICTORIA AVE., SUITE 505 WESTMOUNT, QUEBEC, Canada, H32 2n2, CA
• Contact: George Papagiannis
• Correspondent: George Papagiannis; STELLATE SYSTEMS 345 VICTORIA AVE., SUITE 505 WESTMOUNT, QUEBEC, Canada, H32 2n2, CA
• Product Code: OLT
• CFR Regulation Number: 882.1400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-07-06
• Decision Date: 1998-07-29