GLUCOCARE INTENSIVE GLYCEMIC CONTROL SYSTEM


Device Classification Name

calculator, drug dose

510(k) Number K081388
Device Name GLUCOCARE INTENSIVE GLYCEMIC CONTROL SYSTEM
Applicant
PRONIA MEDICAL SYSTEM, LLC
49 plain street
north attleboro, 
MA 
02760

Applicant Contact cynthia j.m. nolte
Correspondent
PRONIA MEDICAL SYSTEM, LLC
49 plain street
north attleboro, 
MA 
02760

Correspodent Contact cynthia j.m. nolte
Regulation Number 868.1890
Classification Product Code
NDC  
Date Received 05/19/2008
Decision Date 08/21/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No