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510(k) K112601

INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER by Intricon Datrix Corporation — Product Code MWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 2011
Date Received
September 7, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph, Ambulatory (Without Analysis)
Device Class
Class II
Regulation Number
870.2800
Review Panel
CV
Submission Type

Other clearances by Intricon Datrix Corporation

  • K111160 — INTRICON DATRIX CENTAURI MT AMBULATORY PATIENT ECG TELEMETRY SYSTEM (APETS) (August 1, 2011)

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