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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 K992524
Device Name PATIENT CABLES FOR MONITORING, I.E., ECG, EKG, SPO2, AND BP INTERFACE CABLES AND LEADWIRES
Applicant
Advantage Medical Electronics, Inc.
10630 Wiles Rd.
Coral Springs,  FL  33076
Applicant Contact KENNETH E KENDRICKS
Correspondent
Advantage Medical Electronics, Inc.
10630 Wiles Rd.
Coral Springs,  FL  33076
Correspondent Contact KENNETH E KENDRICKS
Regulation Number870.2900
Classification Product Code
DSA  
Date Received07/28/1999
Decision Date 03/01/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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