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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
510(k) Number K994346
Device Name ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM
Applicant
Sendx Medical, Inc.
1945 Palomar Oaks Way
Carlsbad,  CA  92011
Applicant Contact MARTIN SELLERS
Correspondent
Sendx Medical, Inc.
1945 Palomar Oaks Way
Carlsbad,  CA  92011
Correspondent Contact MARTIN SELLERS
Regulation Number862.1120
Classification Product Code
CHL  
Date Received12/23/1999
Decision Date 02/01/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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