MODIFICATION TO INFANT LIFE SUPPORT MODULE-20


Device Classification Name

incubator, neonatal transport

510(k) Number K022876
Device Name MODIFICATION TO INFANT LIFE SUPPORT MODULE-20
Original Applicant
INTERNATIONAL BIOMEDICAL, INC.
8508 cross park dr.
austin, 
TX 
78754

Original Contact gerlad manning
Regulation Number 880.5410
Classification Product Code
FPL  
Date Received 08/30/2002
Decision Date 09/11/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No