GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K022545
Device Name GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020
Original Applicant
HYPOGUARD USA, INC.
5182 west 76th st.
minneapolis, 
MN 
55439

Original Contact bruce a macfarlane
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Code
JQP  
Date Received 08/01/2002
Decision Date 10/11/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No