HYGEIA-5 OXYGEN CONCENTRATOR


Device Classification Name

generator, oxygen, portable

510(k) Number K081267
Device Name HYGEIA-5 OXYGEN CONCENTRATOR
Applicant
KEDL INTERNATION LIMITED
7690 cameron circle
fort myers, 
FL 
33912

Applicant Contact lee leichter
Correspondent
KEDL INTERNATION LIMITED
7690 cameron circle
fort myers, 
FL 
33912

Correspodent Contact lee leichter
Regulation Number 868.5440
Classification Product Code
CAW  
Date Received 05/05/2008
Decision Date 09/23/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No