BILI-THERAPY PAD TYPE


Device Classification Name

unit, neonatal phototherapy

510(k) Number K111547
Device Name BILI-THERAPY PAD 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 06/03/2011
Decision Date 04/12/2012
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