INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER


Device Classification Name

electrocardiograph,ambulatory(without analysis)

510(k) Number K112601
Device Name INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER
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 870.2800
Classification Product Code
MWJ  
Date Received 09/07/2011
Decision Date 11/09/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No