ClearanceBrief
510(k) K011536 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE

ApplicantOridion Medical 1987 , Ltd., Jerusalem, IL
DecisionSubstantially Equivalent, Nov 14, 2001
ReceivedMay 18, 2001
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K011536

DateFirm and productCodeLinked 510(k)
Mar 29, 2012Oridion Medical 1987 Ltd.
Oridion CO2 sampling lines and water traps under the label: MicroStreamC02 Sampling Lines: FilterLine Set Adult/Pediatric -Part No: XS04620-01; FilterLine Set Adult/Pediatric (100 unit boxes)-Part
Terminated		 CCKNone listed
Jul 13, 2010Oridion Medical 1987 Ltd.
Microstream SMART CAPNOLINE PLUS O2 ADU/INT 25UN Part Number: 009822 Oridion 3012176-012 Physio Control
Terminated		 CCKNone listed
Jul 13, 2010Oridion Medical 1987 Ltd.
Microstream SMART CAPNOLINE PLUS O2 LONG ADU/INT 25UN Part Number: 009826
Terminated		 CCKNone listed
Jul 13, 2010Oridion Medical 1987 Ltd.
Microstream SMART CAPNOLINE PLUS O2 100UN Part Number: 010210 Oridion 3012176-112 Physio Control
Terminated		 CCKNone listed
Jul 13, 2010Oridion Medical 1987 Ltd.
Microstream SMART CAPNOLINE H PLUS O2 ADU/INT 25UN Part Number: 010433
Terminated		 CCKNone listed
Jul 13, 2010Oridion Medical 1987 Ltd.
Microstream SCP H PLUS O2 ADU/INT 100UN Part Number: 010625
Terminated		 CCKNone listed
Jul 13, 2010Oridion Medical 1987 Ltd.
Microstream SMART CAPNOLINE PLUS O2 LONG 100 UN Part Number: 010341 010341 Part Number: 10341
Terminated		 CCKNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.