INTRICON DATRIX CENTAURI MT AMBULATORY PATIENT ECG TELEMETRY SYSTEM (APETS)


Device Classification Name

detector and alarm, arrhythmia

510(k) Number K111160
Device Name INTRICON DATRIX CENTAURI MT AMBULATORY PATIENT ECG TELEMETRY SYSTEM (APETS)
Applicant
INTRICON DATRIX CORPORATION
962 allegro lane
apollo beach, 
FL 
33572

Applicant Contact tanya o’brien
Correspondent
INTRICON DATRIX CORPORATION
962 allegro lane
apollo beach, 
FL 
33572

Correspodent Contact tanya o’brien
Regulation Number 870.1025
Classification Product Code
DSI  
Date Received 04/25/2011
Decision Date 08/01/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No