REMbrandt

Automatic Event Detection Software For Polysomnograph With Electroencephalograph

Embla Systems

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

Pre-market Notification Details

• Device ID: K163617
• 510k Number: K163617
• Device Name: REMbrandt
• Classification: Automatic Event Detection Software For Polysomnograph With Electroencephalograph
• Applicant: Embla Systems 1 Hines Road Suite 202 Kanata, CA K2k 3c7
• Contact: Shane T Sawall
• Correspondent: Shane T Sawall; Embla Systems 1 Hines Road Suite 202 Kanata, CA K2k 3c7
• Product Code: OLZ
• CFR Regulation Number: 882.1400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-12-22
• Decision Date: 2017-04-11
• Summary: summary