Company ยท US
Criticare Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1986 to 2010. Name variants (Inc, Corp, punctuation) are merged.
22510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DQA | Oximeter | 4 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 3 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 3 |
| DSI | Detector And Alarm, Arrhythmia | 2 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 2 |
| BTY | Calculator, Predicted Values, Pulmonary Function | 1 |
| CBQ | Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | 1 |
| CBS | Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | 1 |
| DQE | Catheter, Oximeter, Fiber-Optic | 1 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 1 |
| JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | 1 |
| LOS | 1 | |
| MLD | Monitor, St Segment With Alarm | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 1, 2010 | K101602 | VITAL SIGNS MONITOR Criticare Systems, Inc. | MLD |
| May 27, 2009 | K091050 | 506CN PATIENT MONITOR Criticare Systems, Inc. | DRT |
| Sep 29, 2004 | K042569 | 8600 VITAL SIGNS MONITOR Criticare Systems, Inc. | MWI |
| Apr 17, 2003 | K030613 | VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100 Criticare Systems, Inc. | MHX |
| Aug 14, 2002 | K022435 | 507EL VITAL SIGNS MONITOR Criticare Systems, Inc. | DRT |
| Aug 1, 2001 | K012059 | 8100/8500 VITAL SIGNS MONITOR Criticare Systems, Inc. | MWI |
| Apr 28, 2000 | K001020 | 8100 VITAL SIGNS MONITOR Criticare Systems, Inc. | MWI |
| Mar 1, 2000 | K000276 | MPT 24 AND VITAL VIEW 24 Criticare Systems, Inc. | DRG |
| Dec 10, 1996 | K961223 | MULTIPLE PARAMETER TELEMETRY, VITAL VIEW, & MICROVIEW SYSTEMS Criticare Systems, Inc. | LOS |
| Jun 20, 1995 | K944860 | SCHOLAR PATIENT MONITOR Criticare Systems, Inc. | MHX |
| Feb 9, 1995 | K942737 | POET IQ WITH FIVE AGENT CAPABILITY Criticare Systems, Inc. | CBS |
| Dec 17, 1993 | K921309 | MODEL 508 PATIENT MONITOR Criticare Systems, Inc. | BTY |
| Jul 30, 1991 | K910852 | 507 NON-INVASIVE VITAL SIGNS MONITOR Criticare Systems, Inc. | DRT |
| Jun 7, 1991 | K911124 | 503 PULSE OXIMETER Criticare Systems, Inc. | DQA |
| May 14, 1991 | K910770 | 504US PULSE OXIMETER Criticare Systems, Inc. | DQA |
| Oct 30, 1989 | K884643 | 1100 VITAL SIGNS MONITOR Criticare Systems, Inc. | DSI |
| Oct 13, 1989 | K892854 | ANESTHETIC AGENT MONITOR Criticare Systems, Inc. | CBQ |
| Mar 16, 1989 | K884216 | 506 NON-INVASIVE VITAL SIGNS MONITOR Criticare Systems, Inc. | DSI |
| Mar 7, 1988 | K875298 | 502-US PULSE OXIMETER Criticare Systems, Inc. | DQA |
| Jun 2, 1987 | K864745 | POET OXIMETER Criticare Systems, Inc. | DQE |
| Mar 4, 1987 | K864613 | 502 OXYGEN SATURATION MONITOR Criticare Systems, Inc. | DQA |
| Jan 14, 1986 | K853331 | OSM-1 OXYGEN SATURATION MONITOR Criticare Systems, Inc. | JOM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||