510(k) K012478 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER
| Applicant | I-Stat Corp., East Windsor NJ, US |
| Decision | Substantially Equivalent, Aug 20, 2001 |
| Received | Aug 2, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K012478
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.