510(k) K093280 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561
| Applicant | Opti Medical Systems, Inc., Roswell GA, US |
| Decision | Substantially Equivalent, Jan 7, 2011 |
| Received | Oct 20, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093280
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 21, 2012 | OPTI Medical Systems, Inc BP7561 OPTI CCA-TS B-Lac Cassette (25 per box)
Cassettes are consumables used in the OPTI CCA-TS Analyzer intended to be used for in vitro measurements of pH, PCOX2 PO2, lactate (lactic acid), total Terminated |
CHL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.