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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 K002781
Device Name MEDICAL CABLES PATIENT MONITORING CABLES FOR ECG, EEG, SPO2, AND BLOOD PRESSURE MONITORS
Applicant
Medical Cables, Inc.
1340 Logan Ave.
Costa Mesa,  CA  92626
Applicant Contact CHRISTOPHER FONTANA
Correspondent
Medical Cables, Inc.
1340 Logan Ave.
Costa Mesa,  CA  92626
Correspondent Contact CHRISTOPHER FONTANA
Regulation Number870.2900
Classification Product Code
DSA  
Date Received09/06/2000
Decision Date 11/29/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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