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510(k) K111160

INTRICON DATRIX CENTAURI MT AMBULATORY PATIENT ECG TELEMETRY SYSTEM (APETS) by Intricon Datrix Corporation — Product Code DSI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2011
Date Received
April 25, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detector And Alarm, Arrhythmia
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

Other clearances by Intricon Datrix Corporation

  • K112601 — INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER (November 9, 2011)

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