NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM


Device Classification Name

unit, neonatal phototherapy

510(k) Number K103589
Device Name NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM
Applicant
NATUS MEDICAL INCORPORATED
5900 first avenue south
seattle, 
WA 
98108

Applicant Contact julie freed
Correspondent
NATUS MEDICAL INCORPORATED
5900 first avenue south
seattle, 
WA 
98108

Correspodent Contact julie freed
Regulation Number 880.5700
Classification Product Code
LBI  
Date Received 12/07/2010
Decision Date 05/13/2011
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