Company ยท US
Diametrics Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 2003. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 3 |
| CCC | Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling | 2 |
| CBZ | Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling | 1 |
| CGZ | Electrode, Ion-Specific, Chloride | 1 |
| GAA | Needle, Aspiration And Injection, Disposable | 1 |
| GWM | Device, Monitoring, Intracranial Pressure | 1 |
| JFY | Enzymatic Method, Creatinine | 1 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 |
| KHP | Acid, Lactic, Enzymatic Method | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 25, 2003 | K030035 | IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE Diametrics Medical, Inc. | JFY |
| Jan 28, 2002 | K013938 | IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE Diametrics Medical, Inc. | KHP |
| Nov 16, 2001 | K011586 | IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE Diametrics Medical, Inc. | GAA |
| Nov 23, 1999 | K983198 | TRENDCARE CALIBRATOR MODEL SCU 7007 Diametrics Medical, Ltd., GB | CCC |
| Jul 14, 1999 | K980380 | NEUROTREND MULTIPARAMETER SENSOR, C7004S, TO OPERATE WITH PARATREND 7+ MULTIPARAMETER SENSOR, MPM7001S, AND SATELLITE MS Diametrics Medical, Ltd., GB | GWM |
| May 1, 1998 | K981270 | IRMA BLOOD ANALYSIS SYSTEM Diametrics Medical, Inc. | CGZ |
| Mar 19, 1998 | K980523 | IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGE Diametrics Medical, Inc. | CHL |
| Dec 19, 1997 | K972314 | PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM Diametrics Medical, Ltd., GB | CCC |
| Dec 18, 1997 | K974396 | IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULE Diametrics Medical, Inc. | CHL |
| Sep 23, 1997 | K970906 | PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 PLUS MULTIPARAMETER SENSOR Diametrics Medical, Ltd., GB | CBZ |
| Jan 5, 1995 | K945240 | IRMA BLOOD ANALYSIS SYSTEM Diametrics Medical, Inc. | CHL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 30, 2003 | Diametrics Medical, Inc. IRMA SL Blood Analysis System CC pH, pCO2, pO2, Hct, Na+, K+, iCa Cartridge, Part Number 039903(M3586A). There are 25 disposable cartridges in a box of IRMA SL Blood Analysis System CC pH, pCO2, pO2, Terminated |
JJE | K924758 K945240 |