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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cable, transducer and electrode, patient, (including connector)
510(k) Number K093657
Device Name ADAGIO RETRACTING ECG LEAD WIRES
Applicant
ACIST MEDICAL SYSTEMS, INC.
7905 FULLER ROAD
EDEN PRAIRIE,  MN  55344
Applicant Contact AL SAALABI
Correspondent
ACIST MEDICAL SYSTEMS, INC.
7905 FULLER ROAD
EDEN PRAIRIE,  MN  55344
Correspondent Contact AL SAALABI
Regulation Number870.2900
Classification Product Code
DSA  
Date Received11/25/2009
Decision Date 01/15/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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