MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNLOAD CRADLE, AND SERIAL INTERFACE ADAPTOR DO


Device Classification Name

pump, infusion, insulin

510(k) Number K021439
Device Name MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNLOAD CRADLE, AND SERIAL INTERFACE ADAPTOR DO
Original Applicant
ANIMAS CORP.
590 e. lancaster ave.
frazer, 
PA 
19355

Original Contact michael j andrews
Regulation Number 880.5725
Classification Product Code
LZG  
Date Received 05/06/2002
Decision Date 05/29/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No