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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Flow Directed
510(k) Number K925444
Device Name CARDIAC OUTPUT PULMONARY ARTERY CATHETER & MONITOR
Applicant
Ami-Med Corp.
17252 Armstrong Ave.
Suite C
Irvine,  CA  92714
Applicant Contact MAZEN KHOUDARI
Correspondent
Ami-Med Corp.
17252 Armstrong Ave.
Suite C
Irvine,  CA  92714
Correspondent Contact MAZEN KHOUDARI
Regulation Number870.1240
Classification Product Code
DYG  
Date Received10/28/1992
Decision Date 07/19/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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