RHYTHM

Analyzer, Spectrum, Electroencephalogram Signal

STELLATE SYSTEMS

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

Pre-market Notification Details

• Device ID: K912938
• 510k Number: K912938
• Device Name: RHYTHM
• Classification: Analyzer, Spectrum, Electroencephalogram Signal
• Applicant: STELLATE SYSTEMS 345 VICTORIA AVE., SUITE 300 Westmount, Quebec, CA H3z 2n2
• Contact: Gotman
• Correspondent: Gotman; STELLATE SYSTEMS 345 VICTORIA AVE., SUITE 300 Westmount, Quebec, CA H3z 2n2
• Product Code: GWS
• CFR Regulation Number: 882.1420 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-07-05
• Decision Date: 1991-07-30