MEDILED MINI


Device Classification Name

unit, neonatal phototherapy

510(k) Number K103735
Device Name MEDILED MINI
Applicant
MEDIX I.C.S.A.
11874 south evelyn circle
houston, 
TX 
77071 -3404

Applicant Contact james h knauss
Correspondent
MEDIX I.C.S.A.
11874 south evelyn circle
houston, 
TX 
77071 -3404

Correspodent Contact james h knauss
Regulation Number 880.5700
Classification Product Code
LBI  
Date Received 12/22/2010
Decision Date 08/15/2011
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