RPI REPLACEMENT PHOTOTHERAPY LIGHTS


Device Classification Name

unit, neonatal phototherapy

510(k) Number K021531
Device Name RPI REPLACEMENT PHOTOTHERAPY LIGHTS
Original Applicant
REPLACEMENT PARTS INDUSTRIES, INC.
p.o. box 5019
chatsworth, 
CA 
91313 -5019

Original Contact ira lapides
Regulation Number 880.5700
Classification Product Code
LBI  
Subsequent Product Code
FMT  
Date Received 05/10/2002
Decision Date 05/31/2002
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