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FDA 510(k), K210484, LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System
FDA 510(k), K210484, LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System
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510(K) Number: K210484
Device Name: LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System
Manufacturer: Medtronic, Inc.
Device Classification Name: recorder, event, implantable cardiac, (with arrhythmia detection)
Regulation Number: 870.1025
Classification Product Code: MXD
Date Received: 02/19/2021
Decision Date: 06/11/2021
Regulation Medical Specialty: Cardiovascular
Device Name: LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System
Manufacturer: Medtronic, Inc.
Device Classification Name: recorder, event, implantable cardiac, (with arrhythmia detection)
Regulation Number: 870.1025
Classification Product Code: MXD
Date Received: 02/19/2021
Decision Date: 06/11/2021
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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