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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Electric For Gravity Flow Infusion Systems
510(k) Number K853843
Device Name IV MATE
Applicant
Medtech Intl., Inc.
949 S. Orange Blossom Trl.
Apopka,  FL  32703
Applicant Contact JONATHAN ROSEN
Correspondent
Medtech Intl., Inc.
949 S. Orange Blossom Trl.
Apopka,  FL  32703
Correspondent Contact JONATHAN ROSEN
Regulation Number880.2420
Classification Product Code
FLN  
Date Received09/16/1985
Decision Date 01/09/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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