H12+HOLTER RECORDER


Device Classification Name

electrocardiograph,ambulatory(without analysis)

510(k) Number K021373
Device Name H12+HOLTER RECORDER
Original Applicant
MORTARA INSTRUMENT, INC.
7865 north 86th st.
milwaukee, 
WI 
53224

Original Contact harlan l van matre
Regulation Number 870.2800
Classification Product Code
MWJ  
Date Received 05/01/2002
Decision Date 06/27/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No