510(k) K141907 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
STAT PROFILE PRIME CCS ANALYZER SYSTEM, STAT PROFILE PRIME AUTO QC CARTRIDGE CCS, STAT PROFILE PRIME AMPULED CONTROL ABG/CCS, STAT PROFILE PRIME CALIBRTOR CARTRIDGE CCS/CCS COMP, NOVA LINEARITY STANDARD SET A
| Applicant | Nova Biomedical Corporation, Walham MA, US |
| Decision | Substantially Equivalent, May 29, 2015 |
| Received | Jul 15, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141907
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 19, 2017 | Nova Biomedical Corporation Nova Biomedical Stat Profile Prime Analyzer as follows:
PN 52855 Stat Profile Prime ABG Analyzer
PN 53655 Stat Profile Prime ABG Analyzer with Scanner
PN 52856 Stat Profile Prime CCS Analyzer
PN 5 Terminated |
CHL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.