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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 K013121
Device Name MT ALERT INFUSION MONITOR
Applicant
Sierra Biosearch, Inc.
395 Mt. Tom Rd.
Bishop,  CA  93514
Applicant Contact RICHARD CITRENAUM
Correspondent
Sierra Biosearch, Inc.
395 Mt. Tom Rd.
Bishop,  CA  93514
Correspondent Contact RICHARD CITRENAUM
Regulation Number880.2420
Classification Product Code
FLN  
Date Received09/18/2001
Decision Date 10/15/2001
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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