REMI

Reduced- Montage Standard Electroencephalograph

Epitel, Inc.

The following data is part of a premarket notification filed by Epitel, Inc. with the FDA for Remi.

Pre-market Notification Details

• Device ID: K203827
• 510k Number: K203827
• Device Name: REMI
• Classification: Reduced- Montage Standard Electroencephalograph
• Applicant: Epitel, Inc. 124 S. 400 E. Salt Lake City, UT 84111
• Contact: Mark Lehmkuhle
• Correspondent: John Pappan; LeanRAQA 12602 North Summerwind Drive Marana, AZ 85658
• Product Code: OMC
• CFR Regulation Number: 882.1400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-12-29
• Decision Date: 2021-03-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08600053881650	K203827	000
08600053881278	K203827	000