NATUS BLUE LIGHT PHOTOTHERAPY UNIT


Device Classification Name

unit, neonatal phototherapy

510(k) Number K022196
Device Name NATUS BLUE LIGHT PHOTOTHERAPY UNIT
Original Applicant
NATUS MEDICAL, INC.
1501 industrial rd.
san carlos, 
CA 
94070

Original Contact sheila ramerman
Regulation Number 880.5700
Classification Product Code
LBI  
Date Received 07/05/2002
Decision Date 09/19/2002
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

Recalls CDRH Recalls