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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrode, ion-specific, chloride
510(k) Number K973742
Device Name SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM
Applicant
SENDX MEDICAL, INC.
1945 PALOMAR OAKS WAY
CARLSBAD,  CA  92011
Applicant Contact RUBEN CHAIREZ
Correspondent
SENDX MEDICAL, INC.
1945 PALOMAR OAKS WAY
CARLSBAD,  CA  92011
Correspondent Contact RUBEN CHAIREZ
Regulation Number862.1170
Classification Product Code
CGZ  
Subsequent Product Codes
CEM   GKF   JFP   JGS  
Date Received10/01/1997
Decision Date 12/03/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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