X-SCRIBE II


Device Classification Name

electrocardiograph

510(k) Number K022618
Device Name X-SCRIBE II
Original Applicant
MORTARA INSTRUMENT, INC.
7865 north 86th st.
milwaukee, 
WI 
53224

Original Contact harlan van matre
Regulation Number 870.2340
Classification Product Code
DPS  
Date Received 08/07/2002
Decision Date 09/06/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No