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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Thermal, Infusion Fluid
510(k) Number K023653
Device Name MAXONE IV FLUID/BLOOD WARMER, MODEL 102
Applicant
Automatic Medical Technologies, Inc.
1711 N. Bush St.
Santa Ana,  CA  92706
Applicant Contact CINDY MARTIN
Correspondent
Automatic Medical Technologies, Inc.
1711 N. Bush St.
Santa Ana,  CA  92706
Correspondent Contact CINDY MARTIN
Regulation Number880.5725
Classification Product Code
LGZ  
Date Received10/30/2002
Decision Date 01/17/2003
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
Predetermined Change
Control Plan Authorized		 No
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