AVIATOR TRANSPORT INCUBATOR


Device Classification Name

incubator, neonatal transport

510(k) Number K081399
Device Name AVIATOR TRANSPORT INCUBATOR
Applicant
INTERNATIONAL BIOMEDICAL, LTD.
8508 cross park dr.
austin, 
TX 
78754

Applicant Contact amy pieper
Correspondent
INTERNATIONAL BIOMEDICAL, LTD.
8508 cross park dr.
austin, 
TX 
78754

Correspodent Contact amy pieper
Regulation Number 880.5410
Classification Product Code
FPL  
Date Received 05/19/2008
Decision Date 06/06/2008
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