Company ยท US
Sendx Medical Inc
FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2015. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
7recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 7, 2015 | K151639 | ABL80 FLEX and ABL80 FLEX CO-OX Sendx Medical, Inc. | CGA |
| Aug 6, 2015 | K151856 | ABL80 FLEX CO-OX with AQURE connectivity Sendx Medical, Inc. | CHL |
| Jul 31, 2008 | K080370 | ABL 80 CO-OX SYSTEM Sendx Medical, Inc. | CHL |
| Nov 1, 2005 | K051804 | ABL80 FLEX ANALYZER Sendx Medical, Inc. | CHL |
| Feb 1, 2000 | K994346 | ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM Sendx Medical, Inc. | CHL |
| Dec 3, 1997 | K973742 | SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM Sendx Medical, Inc. | CGZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 5, 2012 | Sendx Medical Inc ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35).
The ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximet Terminated |
CHL | K080370 |
| Aug 30, 2012 | Sendx Medical Inc ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - pH Blood Gas and Electrolytes Analyzer System.
Intended Use The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with Terminated |
CHL | K051804 K080370 |
| Apr 9, 2012 | Sendx Medical Inc SenDx Medical Inc
ABL80FLEX
Blood Gas, pH, Electrolyte, and Metabolite System
The ABL80 FLEX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, and hematocrit Terminated |
CHL | K051804 |
| Nov 10, 2009 | Sendx Medical Inc ABL 80 CO-OX SYSTEM, software versions 1.30 and 1.31
Additional Product Codes: CEM, CGA, CGZ, GHS, GKR, GLY, JFP, JGS, JIX, JJY, JPI
The ABL 80 CO-OX SYSTEM is a portable, automated analyzer that me Terminated |
CHL | K080370 |
| Aug 29, 2007 | Sendx Medical Inc ABL8O FLEX Software Version 1.10 included in the ABL8O Flex Analyzer, Model Number 914863 Terminated |
CHL | K051804 |
| Aug 25, 2007 | Sendx Medical Inc ABL80 FLEX Analyzer, Model #393-839 Terminated |
CHL | None listed |
| Aug 18, 2007 | Sendx Medical Inc ABL77 Cal Pack, Model Number 944-069, Lot Number 17323, SenDx Medical Inc., A Radiometer Company Terminated |
CHL | K994346 |