LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System

Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection)

Medtronic, Inc.

The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Linq Ii Insertable Cardiac Monitor, Zelda Ai Ecg Classification System.

Pre-market Notification Details

• Device ID: K210484
• 510k Number: K210484
• Device Name: LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System
• Classification: Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection)
• Applicant: Medtronic, Inc. 8200 Coral Sea Street NE Mounds View, MN 55112
• Contact: Dianna L Johannson
• Correspondent: Dianna L Johannson; Medtronic, Inc. 8200 Coral Sea Street NE Mounds View, MN 55112
• Product Code: MXD
• CFR Regulation Number: 870.1025 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-02-19
• Decision Date: 2021-06-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00763000504533	K210484	000
00763000504526	K210484	000
00763000504519	K210484	000