510(k) K944400 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
PEDI-CAP
| Applicant | Nellcor, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Sep 27, 1994 |
| Received | Sep 8, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944400
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 8, 2009 | Covidien Limited Pedi-Cap CO2 Detector, 1 kg - 15 kg, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Assembled in Mexico. Sold in packages of 6 (PediCap6) or 24 (PediCap).
Intended for u Terminated |
CCK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.