BILI-THERAPY SPOT TYPE


Device Classification Name

unit, neonatal phototherapy

510(k) Number K103828
Device Name BILI-THERAPY SPOT TYPE
Applicant
ATOM MEDICAL CORPORATION
24301 woodsage drive
bonita springs, 
FL 
34134

Applicant Contact paul dryden
Correspondent
ATOM MEDICAL CORPORATION
24301 woodsage drive
bonita springs, 
FL 
34134

Correspodent Contact paul dryden
Regulation Number 880.5700
Classification Product Code
LBI  
Date Received 12/28/2010
Decision Date 03/29/2011
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