Criticare Systems, Inc.
Waukesha, WI, US
Criticare Systems, Inc. appears in FDA device records in Waukesha, WI. FDA records list 22 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 22
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 22 510(k) clearances for Criticare Systems, Inc. between 1986 and 2010. The busiest year on record is 1989, with 3. The most recent is 2010, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 1 |
| 1987 | 2 |
| 1988 | 1 |
| 1989 | 3 |
| 1991 | 3 |
| 1993 | 1 |
| 1995 | 2 |
| 1996 | 1 |
| 2000 | 2 |
| 2001 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K101602 | VITAL SIGNS MONITOR | MLD | Substantially Equivalent | |
| K091050 | 506CN PATIENT MONITOR | DRT | Substantially Equivalent | |
| K042569 | 8600 VITAL SIGNS MONITOR | MWI | Substantially Equivalent | |
| K030613 | VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100 | MHX | Substantially Equivalent | |
| K022435 | 507EL VITAL SIGNS MONITOR | DRT | Substantially Equivalent | |
| K012059 | 8100/8500 VITAL SIGNS MONITOR | MWI | Substantially Equivalent | |
| K001020 | 8100 VITAL SIGNS MONITOR | MWI | Substantially Equivalent | |
| K000276 | MPT 24 AND VITAL VIEW 24 | DRG | Substantially Equivalent | |
| K961223 | MULTIPLE PARAMETER TELEMETRY, VITAL VIEW, & MICROVIEW SYSTEMS | LOS | Substantially Equivalent | |
| K944860 | SCHOLAR PATIENT MONITOR | MHX | Substantially Equivalent | |
| K942737 | POET IQ WITH FIVE AGENT CAPABILITY | CBS | Substantially Equivalent | |
| K921309 | MODEL 508 PATIENT MONITOR | BTY | Substantially Equivalent | |
| K910852 | 507 NON-INVASIVE VITAL SIGNS MONITOR | DRT | Substantially Equivalent | |
| K911124 | 503 PULSE OXIMETER | DQA | Substantially Equivalent | |
| K910770 | 504US PULSE OXIMETER | DQA | Substantially Equivalent | |
| K884643 | 1100 VITAL SIGNS MONITOR | DSI | Substantially Equivalent | |
| K892854 | ANESTHETIC AGENT MONITOR | CBQ | Substantially Equivalent | |
| K884216 | 506 NON-INVASIVE VITAL SIGNS MONITOR | DSI | Substantially Equivalent | |
| K875298 | 502-US PULSE OXIMETER | DQA | Substantially Equivalent | |
| K864745 | POET OXIMETER | DQE | Substantially Equivalent | |
| K864613 | 502 OXYGEN SATURATION MONITOR | DQA | Substantially Equivalent | |
| K853331 | OSM-1 OXYGEN SATURATION MONITOR | JOM | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CBQAnalyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
- CBSAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
- BTYCalculator, Predicted Values, Pulmonary Function
- DQECatheter, Oximeter, Fiber-Optic
- DSIDetector And Alarm, Arrhythmia
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- MLDMonitor, St Segment With Alarm
- DQAOximeter
- JOMPlethysmograph, Photoelectric, Pneumatic Or Hydraulic
- DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain