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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name oximeter
510(k) Number K973970
Device Name SPO2 FINGER PROBES
Applicant
MEDICAL CABLES, INC.
1340 LOGAN AVE.
COSTA MESA,  CA  92626
Applicant Contact CHRISTOPHER J FONTANA
Correspondent
MEDICAL CABLES, INC.
1340 LOGAN AVE.
COSTA MESA,  CA  92626
Correspondent Contact CHRISTOPHER J FONTANA
Regulation Number870.2700
Classification Product Code
DQA  
Date Received10/17/1997
Decision Date 10/06/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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