DAHEDI INSULIN INFUSION PUMP


Device Classification Name

pump, infusion, insulin

510(k) Number K991376
Device Name DAHEDI INSULIN INFUSION PUMP
Applicant
DISETRONIC MEDICAL SYSTEMS
7690 cameron circle
ft. meyers, 
FL 
33912

Applicant Contact lee leichter
Correspondent
DISETRONIC MEDICAL SYSTEMS
7690 cameron circle
ft. meyers, 
FL 
33912

Correspodent Contact lee leichter
Regulation Number 880.5725
Classification Product Code
LZG  
Date Received 04/21/1999
Decision Date 06/15/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls