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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K823406
Device Name GUARDIAN 110, VOL. CONTROL DELIV. SYS
Applicant
Avi, Inc.
MN 
Correspondent
Avi, Inc.
MN 
Regulation Number880.5725
Classification Product Code
FRN  
Date Received11/15/1982
Decision Date 12/22/1982
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
Recalls CDRH Recalls
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