510(k) K010795 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
CAPNOPROBE SL, MODEL 2000
| Applicant | Optical Sensors, Inc., Stoughton WI, US |
| Decision | Substantially Equivalent, Apr 11, 2001 |
| Received | Mar 16, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K010795
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 2, 2004 | Nellcor Puritan Bennett The probes involved have been part of the Nellcor CapnoProbeTM SLS~1 Sublingual System. The CapnoProbe system consists of an N-80 CapnoProbe device and an SLS-1 Sublingual Sensor, or probe. Each pr Terminated |
CCK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.