BRIGHT EMBRACE MODEL SBL60


Device Classification Name

unit, neonatal phototherapy

510(k) Number K110550
Device Name BRIGHT EMBRACE MODEL SBL60
Applicant
PHYSICIAN ENGINEERED PRODUCTS, INC.
103 smith st.
fryeburg, 
ME 
04037

Applicant Contact robert rose
Correspondent
PHYSICIAN ENGINEERED PRODUCTS, INC.
103 smith st.
fryeburg, 
ME 
04037

Correspodent Contact robert rose
Regulation Number 880.5700
Classification Product Code
LBI  
Date Received 02/25/2011
Decision Date 02/03/2012
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