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: K160809
• 510k Number: K160809
• Device Name: Reveal LINQ
• Classification: Detector And Alarm, Arrhythmia
• Applicant: MEDTRONIC, INC. 8200 CORAL SEA ST NW Mounds View, MN 55112
• Contact: Dianna L Johannson
• Correspondent: Dianna L Johannson; MEDTRONIC, INC. 8200 CORAL SEA ST NW Mounds View, MN 55112
• Product Code: DSI
• CFR Regulation Number: 870.1025 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-03-24
• Decision Date: 2016-05-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00643169636651	K160809	000