510(k) K012395 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
MAC-LINE 02/CO2 NASAL CANNULA SAMPLE LINE
| Applicant | Oridion Medical 1987 , Ltd., Jerusalem, IL |
| Decision | Substantially Equivalent, Aug 15, 2001 |
| Received | Jul 27, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K012395
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 30, 2012 | Oridion Medical 1987 Ltd. Oridion Surestream CO2 Sampling Lines-
SureLine O2
Part Number: 010979-03
Product Usage:
The intended use of SureStream sampling lines is to convey a sample of a patients expired breath to a capnogr Terminated |
CCK | None listed |
| Mar 29, 2012 | Oridion Medical 1987 Ltd. Oridion CO2 sampling lines and water traps under the label:
Surestream CO2 Sampling Lines:
SureLine Adult Part No.010976;
sureLine Pediatric Part No. 010977;
SureLine O2 Adult Part No.010979 Terminated |
CCK | None listed |
| Mar 29, 2012 | Oridion Medical 1987 Ltd. Oridion CO2 sampling lines and water traps under the label:
Omnistream CO2 Sampling Lines:
OmniLine O2 Adult Part No.007609;
OmniLine O2 Pediatric Part No 007610;
Smart OmniLine Plu Terminated |
CCK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.