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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 K844309
Device Name IV RATEMETER
Applicant
Aci Medical, Inc.
8835 Mulberry Dr.
P.O. Box 1134
Sunland,  CA  91040
Applicant Contact EDWARD J ARKANS
Correspondent
Aci Medical, Inc.
8835 Mulberry Dr.
P.O. Box 1134
Sunland,  CA  91040
Correspondent Contact EDWARD J ARKANS
Regulation Number880.2420
Classification Product Code
FLN  
Date Received11/06/1984
Decision Date 01/22/1985
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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