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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 K923561
Device Name AC-901 I.V. INFUSION DROP COUNTER
Applicant
Lamtic, Inc.
18 Technology Dr., Suite 138
Irvine,  CA  92718
Applicant Contact ALFRED M WU
Correspondent
Lamtic, Inc.
18 Technology Dr., Suite 138
Irvine,  CA  92718
Correspondent Contact ALFRED M WU
Regulation Number880.2420
Classification Product Code
FLN  
Date Received07/17/1992
Decision Date 05/26/1993
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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