Reveal LINQ

Detector And Alarm, Arrhythmia

Medtronic, Inc.

The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Reveal Linq.

Pre-market Notification Details

• Device ID: K162855
• 510k Number: K162855
• Device Name: Reveal LINQ
• Classification: Detector And Alarm, Arrhythmia
• Applicant: Medtronic, Inc. 8200 Coral Sea Street NE Mounds View, MN 55112
• Contact: Syed Sumran Mohiuddin
• Correspondent: Syed Sumran Mohiuddin; Medtronic, Inc. 8200 Coral Sea Street NE Mounds View, MN 55112
• Product Code: DSI
• CFR Regulation Number: 870.1025 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-10-12
• Decision Date: 2017-02-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00643169845749	K162855	000
00643169845893	K162855	000