DUO-MAX BLOOD PRESSURE & GLUCOSE MONITOR HMF-100


Device Classification Name

glucose oxidase, glucose

510(k) Number K080636
Device Name DUO-MAX BLOOD PRESSURE & GLUCOSE MONITOR HMF-100
Applicant
HUBDIC CO., LTD
55 northern blvd., suite 200
great neck, 
NY 
11021

Applicant Contact maria f griffin
Correspondent
HUBDIC CO., LTD
55 northern blvd., suite 200
great neck, 
NY 
11021

Correspodent Contact maria f griffin
Regulation Number 862.1345
Classification Product Code
CGA  
Subsequent Product Codes
DXN   JJX   NBW  
Date Received 03/06/2008
Decision Date 02/13/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No