MAXONE, BLOOD, BLOOD PRODUCTS AND IV FLUID WARMER


Device Classification Name

warmer, thermal, infusion fluid

510(k) Number K002409
Device Name MAXONE, BLOOD, BLOOD PRODUCTS AND IV FLUID WARMER
Original Applicant
AUTOMATIC MEDICAL TECHNOLOGIES, INC.
3422 west pico blvd.
los angeles, 
CA 
90019

Original Contact michael mitsunaga
Classification Product Code
LGZ  
Subsequent Product Code
BSB  
Date Received 08/07/2000
Decision Date 06/28/2001
Decision

substantially equivalent

(SESE)

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No