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510(k) K212008

Reveal LINQ Insertable Cardiac Monitor by Medtronic, Inc. — Product Code MXD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2021
Date Received
June 28, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

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Other clearances for product code MXD

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  • K231328 — LUX-Dx II (M302); LUX-Dx II+ (M312) (August 19, 2023)
  • K230375 — BIOMONITOR IV (May 19, 2023)
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