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Sendx Medical Inc

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
6
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2304-2012Class IIABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - pH Blood Gas and ElectrJune 6, 2012
Z-0195-2013Class IIABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35). The ABL80 FLEX CJanuary 6, 2010

Recent 510(k) Clearances

K-NumberDeviceDate
K151639ABL80 FLEX and ABL80 FLEX CO-OXDecember 7, 2015
K151856ABL80 FLEX CO-OX with AQURE connectivityAugust 6, 2015
K080370ABL 80 CO-OX SYSTEMJuly 31, 2008
K051804ABL80 FLEX ANALYZERNovember 1, 2005
K994346ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEMFebruary 1, 2000
K973742SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEMDecember 3, 1997